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6.0 - 11.0 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55
Posted 4 weeks ago
1.0 - 4.0 years
7 - 10 Lacs
Hyderabad, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are looking to hire Narrative Medical Writers for our Client. Please go through the JD and Apply Role : Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 365 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 366 c) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 367
Posted 4 weeks ago
2.0 - 7.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 184 b) To Apply for above Job Role ( Pune ) Type : Job Code # 185 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 186
Posted 4 weeks ago
2.0 - 7.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 184 b) To Apply for above Job Role ( Pune ) Type : Job Code # 185 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 186
Posted 4 weeks ago
4.0 - 8.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183
Posted 4 weeks ago
7.0 - 12.0 years
15 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the ITES Company for the position of SAS: Statistical Programmer Job Description: We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209
Posted 4 weeks ago
1.0 - 6.0 years
10 - 15 Lacs
Bangalore Rural, Bengaluru
Work from Office
Hi, We are hiring for the Leading ITES Company for Medical Writing Role. Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required Key Skills: a) Min 1 Year Experience in Clinical Study and Summary Writing Common Technical Document. b) Should have Experience in making Clinical Study Pharmacology Report, Clinical Study Report and Clinical Summary of Safety c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396
Posted 4 weeks ago
6.0 - 11.0 years
10 - 15 Lacs
Navi Mumbai, Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the job role of Medical Writer Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57
Posted 4 weeks ago
7.0 - 10.0 years
10 - 20 Lacs
Hyderabad, Bengaluru
Work from Office
Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 375 b) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 376
Posted 4 weeks ago
7.0 - 10.0 years
10 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 373 b) To Apply for above Job Role ( Pune ) Type : Job Code # 374
Posted 4 weeks ago
3.0 - 6.0 years
9 - 12 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of Clinical Data Manage (CDM) with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207
Posted 4 weeks ago
2.0 - 7.0 years
9 - 12 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & Responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207
Posted 4 weeks ago
6 - 10 years
8 - 15 Lacs
Indore, Hyderabad, Chennai
Work from Office
Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Lead Profile. Job Description: Minimum 9 + years of experience with Pharmaceutical or CRO industry engaged in Clinical and Preclinical Research Good understanding of applied statistical principles and modeling in the design and analysis of clinical studies Good understanding of ICH and regulatory guidelines Experience in CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming. Good communication and interpersonal skills Experience in handling domain interactions with the customer. Preferred Educational Qualification for the role: Masters or Doctorate level degree in Biostatistics, Statistics, Mathematics or related fields . Essential Experience for the Role : Good knowledge and hands on experience in R and SAS Statistical Programming in Clinical Domain To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Hyderabad Search : Job Code # 294 b) For Position in Chennai Search : Job Code # 295 c) For Position in Indore Search : Job Code # 296
Posted 1 month ago
2 - 7 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database • Responsible & Accountable for the assigned study conduct activities, in clinical trials • Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. • Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. • To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). • SPOC for the study communications • Proactively highlight any risks associated with the study along with the mitigation plan. • Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. • Identify process Improvement opportunities and ensure learning is shared • Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. • Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. • Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 C) For Position in Bangalore Search : Job Code # 186
Posted 1 month ago
2 - 7 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 c) For Position in Bangalore Search : Job Code # 186
Posted 1 month ago
7 - 12 years
15 - 20 Lacs
Nagpur, Bangalore Rural, Bengaluru
Work from Office
Hi We are Hiring for the ITES Company for the position of SAS : Statistical Programmer Job Description: We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : Statistical Programmer Nagpur (Job Code # 210) b) For Position in Bangalore Search : Statistical Programmer Bangalore (Job Code # 211)
Posted 1 month ago
7 - 12 years
15 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the ITES Company for the position of SAS: Statistical Programmer Job Description: We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209)
Posted 1 month ago
7 - 10 years
10 - 20 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 373 b) For Position in Pune Search : Job Code # 374
Posted 1 month ago
7 - 10 years
10 - 20 Lacs
Hyderabad, Bengaluru
Work from Office
Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 375 b) For Position in Hyderabad Search : Job Code # 376
Posted 1 month ago
4 - 8 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 181 b) For Position in Pune Search : Job Code # 182 C) For Position in Bangalore Search : Job Code # 183
Posted 1 month ago
4 - 8 years
9 - 15 Lacs
Hyderabad, Pune, Bengaluru
Work from Office
Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search: Job Code # 483 b) For Position in Bangalore Search: Job Code # 484 c) For Position in Hyderabad Search: Job Code # 485
Posted 1 month ago
3 - 6 years
9 - 12 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of Clinical Data Manage (CDM) with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 205 b) For Position in Pune Search : Job Code # 206 C) For Position in Bangalore Search : Job Code # 207
Posted 1 month ago
2 - 7 years
9 - 12 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & Responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 205 b) For Position in Pune Search : Job Code # 206 C) For Position in Bangalore Search : Job Code # 207
Posted 1 month ago
7 - 12 years
9 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Description To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)
Posted 1 month ago
5 - 10 years
10 - 15 Lacs
Pune, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55
Posted 1 month ago
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