18 Data Review Jobs

Serve independently as a Clinical Data Coder and/or Lead Coder or DOC for one or more protocols. Manage delivery of coding activities and/or stand alone coding projects through full study life-cycle (with minimal guidance). Validates/tests the coding application and programming of coding reports may also test coding related datasets, coding related edits or any coding related programming activities. Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications. Manage coding related project timelines with guidance from the DOC or Data Team Lead (DTL) or Manager. Perform Serious Adverse Event (SAE) reconciliation activities. May serve as a back-up for a Lead Coder, DOC or DTL. Perform comprehensive quality control procedures, Assist in implementing new technology. Independently bring coding and project related solutions to the DM team. Handle audit requirements for respective studies including stand-alone coding projects as applicable. Understand and comply with core operating procedures and work instructions. Perform other duties as directed by the study team or Manager, or meet objectives as assigned Develop and maintain good communication and working relationship with the team. Qualifications Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent 2 years of relevant experience or equivalent combination of education, training and experience. Excellent knowledge of medical terminologies, pharmacology, anatomy and physiology. In-depth knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD etc.). Understanding of the Data Management process from study start-up through to database lock. Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems. Good understanding of database technologies related to data management and coding. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Excellent written and oral communication skills in English language, organizational and leadership skills. Ability to establish and maintain effective working relationships with co-workers, managers and clients. LPN - Licensed Practical Nurse - State Licensure Req

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Qualification BSc,Master of Pharmacy

Role & responsibilities Responsible for following activities: a. Verify cGMP, GDP, GLP and data integrity practices, compliance in Quality Control and microbiology laboratory. b. Review of Specification, Standard test procedures and test data sheet for adequacy and accuracy. c. Review Validation and calibrations of all Instruments. d. Review of AMV, AMT Protocols and reports. e. Handling of Lab incidents, Deviations, OOS, OOC, OOT etc. f. Handling of reserved sample of finished products and its visual inspection. g. Review of trend data of environmental monitoring, water analysis. h. Participation in audit the contract testing laboratory. Preferred candidate profile ERP/ QMS/QC software system handling experience

Outpace Consulting Services is seeking a Medical Writer specializing in Life Sciences and Clinical Studies for a leading ITES company. This role is responsible for developing clear, accurate, and well-structured medical and scientific documents for various audiences, including regulatory authorities. You'll translate complex clinical and scientific data into understandable content for regulatory submissions, clinical trial documentation, and other critical materials. The ideal candidate will have strong writing skills, a solid understanding of medical terminology and research practices, and experience with regulatory submission formats. Key Responsibilities: Clinical Document Preparation: Prepare and review clinical documents for regulatory submission, including but not limited to Protocols, Clinical Study Pharmacology Reports, Clinical Study Reports, Narratives, Post-Approval Documents, Clinical Summary of Safety, Clinical Summary of Efficacy, and Common Technical Document (CTD) Modules across various Therapeutic Areas. Quality Assurance: Conduct thorough quality checks of all clinical documents intended for regulatory submission, ensuring scientific content, organization, clarity, accuracy, format, and consistency meet high standards and regulatory guidelines. Regulatory Compliance: Ensure all prepared medical writing documents adhere to Standard Operating Procedures (SOPs), Document Standards, Guidance documents, regulatory guidelines, and applicable standards/styles. Team Coordination: Initiate start-up meetings with study teams, and work in close coordination with all internal and external study team members for the creation and development of clinical documents. Share project timelines with the study team. Data Review & Integration: Review statistical analysis plans and table/figure/listing, when required, ensuring uniformity and consistency in the scientific content of all regulatory documents. Project Management Support: Take an active role in assigned projects for planning content, format, and timing of documents, and report scheduling/tracking. Provide support to the clinical development or project team to meet project needs and department standards within established timelines. Peer Review & Quality Control: Perform peer review and quality control review of documents within established timelines, adhering to applicable guidelines and processes using appropriate checklists. Required Qualifications: Experience: Minimum 1 year of experience in eCTD / NEES / Docubridge . Demonstrated experience in making Clinical Study Reports and Clinical Summary of Safety . Education: Any Life Science Graduate. Skills: Strong writing skills, attention to detail, and a solid understanding of medical terminology and research practices. To Apply: WhatsApp Hi to +91 9151555419 . Then, follow these steps: Click on Start option to Apply and fill the details. Select the location as Other (to get multiple location options). a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396

Corporate Title: Assistant Vice President To comply with both US and Global regulations, the Financial Market Infrastructure (FMI) Operations team must ensure there are Contingency Strategy (CS) documents in place for all material relationships held with FMIs and Agent Banks, to support continued access to key services in a stress scenario. The CS document describes the actions which could be taken by the FMI and how the DB Group could respond, ahead of and during resolution. To determine which relationships require a CS, an annual global data collection is coordinated by the FMI Operations team, which drives a materiality assessment to determine the key relationships for the DB group. The creation/refresh of a CS involves being able to review and interpret global regulatory guidance, to ensure the CS is adapted to evolving requirements. The team also engage with Business, Operations, Treasury, Legal, and Risk Management functions to gather their feedback and input. Your key responsibilities Support the completion of the annual data gathering outreach, including data validation / review. Analyze and interpret regulatory guidance and enhance existing contingency strategies to meet regulatory requirements. Independently manage the review/creation of multiple CSs for FMIs / Agent Banks ensuring a high and consistent standard of quality. Effectively manage communication, feedback and approval from internal senior stakeholders. Perform quality and consistency reviews of contingency strategies. Provide support for the Team lead / process oversight and governance. Your skills and experience Excellent reading and writing skills, with ability to independently draft new documentation suitable for regulatory submission. Strong ability to scrutinise extensive documentation, review and interpret regulatory guidance, to incorporate to the CS. Analytical and communications skills; effectively host meetings with multiple stakeholder groups including senior management/external audiences. Confident data review, analysis and presentation (pivots/v-lookup/text functions/formulas/SharePoint/PowerPoint/Excel) with high and consistent attention to detail. Ability to prioritise and effectively manage workload across multiple workstreams, working within tight time frames, providing accurate updates, escalations and highlighting remedial actions. Desirable to have; Understanding of Living Wills / Recovery and Resolution Planning and other applicable regulations. Understanding of the operations and functions of clearing houses, central securities depositories, and payment systems. Understanding of securities & cash products. Previous operational (settlement and clearing) industry experience Team or process lead/management experience

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Basic Minimum Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Education/Experience: A masters degree in microbiology Additional Information Experience level :02 years of pharmaceutical experience preferred. Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

At Burns & McDonnell India (BMI OGC), you'll be joining the ranks of our Piping Design & Engineering team. You'll report to department & functional managers, and your focus? The engineering design of projects spanning across sectors such as Oil, Gas, Chemicals, Petrochemicals, Renewable Fuels, Decarbonization, and Carbon Capture. And these projects aren't limited to a local scale; they are positioned globally, reflecting our worldwide impact. You'll be a part of our vibrant Oil, Gas, and Chemicals (OGC) Global Practice, a thriving collective of around 500+ professionals. This dynamic group lives and breathes engineering, procurement, and construction projects across various industries - Refining, Midstream & Logistics, Petrochemical, and Chemicals. So, are you ready to take on challenges that shape industries and transform lives? Dive into the exciting world of Burns & McDonnell India, where your contribution will be part of our global footprint. Roles & Responsibilities: Analysis experience of Static & Rotary equipment. Nozzle load limit check, flange definition for flange leakage qualification, piping specials, and accuracy checking of Input. Analysis of Stress model for Code stresses check [Sustain, Expansion, Occasional stresses], Displacement, Flange Leakage qualification using ASME Sec VIII, Equipment Nozzle loads/ Pipe Support qualification wrt. to vendor allowable / as per applicable code / Qualification using Nozzle-pro (where applicable). Define Pipe Support requirement as per analysis and its support tagging and marking the stress comments on Isometrics. Preparation of support loads for Civil & Structural group. Preparation of documentation for Independent Quality Review. Preparation of procurement specification with log sheet for Piping Specials like Cold Shoe, Spring, Rod Hanger, Struts, Snubbers, Expansion joints, etc., their TBA, and vendor drawing review. Position may require interface and coordination with other engineering disciplines, designers, and detailers locally in the Mumbai office as well as remotely in various offices in the United States. Knowledge in Piping engineering, Conceptual pipe routing and layout, Pipe and Valve materials specification preparation, piping specials, technical bid evaluation, Vendor data review and approval, isometrics checking, and approval would be an added advantage. - Bachelor’s Degree in Mechanical/Chemical engineering 5-12 years of experience in detailed stress analysis associated with Energy/Oil & Gas projects. Advanced understanding and proficient experience of design software such as Caesar II, knowledge of AutoPipe is added advantage. Hands-on experience of Navisworks, SPR and Excel to develop design deliverables is preferred. Engineers having experience in preparation of Piping Material Specification will be preferred. Familiar with Energy/Oil & Gas industry codes and standards including ASME & API.

Experience of reviewer data review of method validation. Document review like STP, Protocols and Reports of AMV , verification. Monitoring of daily activities Preparation and review of Validation Protocol, Report, SOP and Specifications, analysis.

Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Processing of simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations Communication in writing and in person with laboratory personnel in an intelligent and clear manner Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, chemical identification, and other subjective review based on testing performed; perform complex calculations to verify results Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology May serve as technical advisor for analysts with regard to QA/QC of data Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees Attention to details Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Education/Experience (BMQ): Masters degree in a pharma / science-related field with at least 8-10 years of experience or Ph. D degree (preferred) with 5 years in Bio/Pharmaceutical Analysis experience with knowledge of regulatory requirements and data review responsibilities Experience with chromatography and mass spectrometry analytical techniques (HPLC, GC, LC/MS, GC/MS) Experience identifying unknown compounds by mass spectrometry (ideally by LC/MS-TOF and/or LC/MS-QTOF) Additional Preferences: Experience with Agilent MassHunter software Experience with extractables and leachables testing Knowledge of USP/EP compendia, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience Strong Math Skills Logical Thinking, Good Reasoning Ability Motivation to excel Coaching/mentoring of peers

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualifications Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Clinical Data Analyst Location: Bangalore, Hyderabad, Mumbai Education: Science Graduate Experience: 3+ years Notice Period: Immediate Joiners Preferred Skills: SQL, SAS, MACROS, Lifesciences, Clinical domain, Clinical trials, data reporting/review

Data Analyst II Job Description Manage data cleaning activities for specified clients/studies Liaise directly with client/CRO DMs to develop a query management strategy during study start-up Enact and maintain data cleaning schedule in accordance with the established query management strategy ¢ Maintain visibility to data lock schedules and ensure reconciliation is complete prior to data lock periods ¢ Ensure a seamless communication and follow up with our selected external client and internal clients. ¢ Analyze client data discrepancies. Update database accordingly to the clients needs and in compliance with the GCP rules when appropriate. ¢ Lead the communication with the other departments in relation to the discrepancy solving until resolution. ¢ Provide direct answers to the selected external client or internal clients and provide advice when the request is not directly feasible. ¢ Negotiate the timelines when needed. ¢ Involve selected external clients or internal client in decision making to ensure clients needs are being considered. ¢ Act as primary strategic representative between selected external clients and other Covance departments in the scope of the data reconciliation. ¢ Review the study Statement of Work to ensure compliance of the request with the protocol when appropriate. ¢ Perform quality checks on data revisions and answers provided to clients. ¢ Generate and review Covance database reports and resolve issues as needed. ¢ Lead escalation of issues that may impact resolution of the discrepancies on time. Manage workload and priorities to ensure all clients deadlines are respected. ¢ Work in a team-oriented, global environment with the focus on customer service, both internal and external. ¢ Assist and support management in the implementation of global processes and procedures ensuring seamless integration. ¢ Responsible for effective and timely adherence to management communications, meeting and procedures. ¢ Support a culture of continuous improvement, quality and productivity. ¢ Assist management team with audits, reportable issues, CAIRs, and other quality issues as needed. ¢ Responsible for providing expert technical and administrative support to CLS data processing systems and act as a lead in resolving process and or application issues as necessary.

Review and approval of analytical documents generated in the QC lab (e.g., STPs, COAs, protocols, reports). Perform thorough investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents in coordination with QC. Ensure timely closure of investigations with proper root cause identification and implementation of CAPA. Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements. Support data integrity initiatives and audit readiness in the QC laboratory. Participate in internal and external audits, including those by USFDA and other regulatory bodies. Review and trend analytical data to ensure ongoing process verification and product quality. Collaborate with cross-functional teams (QC, Production, Regulatory Affairs, etc.) for continuous improvement. Desired Candidate Profile: Education: B.Pharm / M.Pharm / M.Sc in Chemistry or related field Experience: 10+ years of experience in Analytical Quality Assurance or QC in a pharmaceutical manufacturing environment, preferably in oral solid dosage (tablets) Hands-on experience in handling analytical investigations in a QC lab Experience in facing USFDA or other international regulatory audits Strong understanding of cGMP, ICH guidelines, and data integrity requirements Good communication and documentation skills

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Specialist Qualifications: BSc/Master of Pharmacy Years of Experience: 7 to 11 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Preferred candidate profile Looking for a candidate with 2 to 4 years of work experience as QC analyst /AQA reviewer in reputed pharma companies. Should have Knowledge of handling/analytical data review of HPLC, FTIR, UV spectrophotometer, KF Autotitrator, Dissolution apparatus. Have Basic knowledge of CGMP, GDP, Data integrity. Should have Basic knowledge of OOS (Out of specification), OOT (Out of rend), OOC (Out of calibration).