1- 2yr of Clinical Data Management Experience . Perform/Assist the Data Manager in managing various data management projects as per sponsor requirements and to provide efficient, quality management products. Support coordinate with other departments, sites and sponsors as and when necessary Essential Functions Perform/Assist regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor. Serve in the role of back-up to a Sr. Data Coordinator or Data Team Lead. Manage the allocated tasks with minimum oversight. Ensure that all the deliverables are of expected quality standards and meet customer expectations with support of Senior Data Manager. Interact with Data Management team leaders to report on the quality of data collection and tasks done. Attend internal study meetings and internal/ sponsor audits. Assist in tracking and managing the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended by DTL. Be compliant to trainings and eSOP reading. Communication with Data Team Lead and other team members across functions should be collaborative. Qualifications Bachelors Degree Graduate Science/Bachelor Pharmacy or equivalent Pref English Fluency Spoken and English Basic computer applications like Microsoft excel, word, Inbox etc Should have basic understanding of Drug development lifecycle and Overall Clinical research process

Assists with the design/development of software solutions requiring general domain knowledge and limited business expertise. Troubleshoots code issues and continuously evolves IQVIAs platforms to meet user requirements/needs. Essential Functions Assists with the design/development of software solutions requiring general domain knowledge and limited business expertise. Works at all layers of the application stack including front-end user interface and backend development. Troubleshoots code issues and continuously evolves IQVIAs platforms to meet user requirements/needs. Reviews functional specifications and other validation deliverables as assigned. Develops a basic understanding of industry and IQVIA-specific quality standards. Supports development projects based on specific instructions and with limited discretion. Typically requires 1 year of prior relevant experience with MuleSoft. Qualifications Bachelors Degree Computer Science, a related field, or equivalent experience Mandatory skills-- Min 1 year of relevant experience on MuleSoft implementation and Anypoint platform (mandatory). Min 1 year of relevant experience on python implementation (mandatory). Min 1 year of hands-on experience with database implementation using snowflake / Oracle (mandatory) Good to Have - Exposure to Salesforce CRM platform, SOQL and Salesforce API integration. Exposure to Reltio MDM

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (eg, coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients

Job Posting Title Technical Writer Job description Collaborate with teams such as engineering, quality, product management, release management, and other experts to create documentation focused on user education. Independently plan, research, and create comprehensive technical documentation from the ground up for new products and features with minimal initial guidance . Develop a wide array of user education materials, ranging from clear and effective product documentation (e.g., user guides, FAQs) to engaging and interactive online training modules (e.g., tutorials, knowledge base articles). Proactively conduct interviews with subject matter experts and meticulously analyze product specifications, design documents, and other technical resources to acquire in-depth knowledge. Rigorously ensure the accuracy, clarity, consistency, and grammatical correctness of all technical documentation, adhering to established style guides and standards. Mandatory skills Creates top-notch, detailed, and precise documentation that is centered around the user. Has a combination of excellent communication abilities, a positive mindset, and an enthusiasm for mastering new tools and technologies. Is self-motivated and resourceful, capable of working independently with little assistance. Can resolve problems with publishing tools independently, without needing help from other team members. Has the ability to work efficiently and handle pressure effectively. Desired Skills Utilize proficiency in technical communication methods to enhance processes such as Document Development, Maintenance, and Support. Working knowledge of Jira and Confluence, or similar platforms. Working knowledge of either MadCap Flare or Adobe RoboHelp. Awareness of Digital Adoption Platforms, which are increasingly being used to enhance user assistance and onboarding experiences. Proficient in working with numbers and calculations. Experience as an effective technical writer, preferably in an agile development environment. Requirements Bachelor s degree in English, Computer Science, Technical Writing, or a related field of study. 4-6 years of core technical writing experience Excellent verbal, written, presentation, and interpersonal communication skills.

Liaise with investigator sites to notify of alert values, critical values, data clarifications and data revision requests. Act as primary contact for clinical investigator sites. Resolve issues for study coordinators concerning any aspect of the laboratory services in a timely manner. Facilitate the flow of information between investigator site and Project Management. Liaise with internal stakeholders in order to facilitate the laboratory sampling process. Ensure that Project Management team is made aware of any information that may influence the smooth running of a particular project. Retrieve voicemail messages concerning supply orders, test or document requests, call backs etc. in a prompt manner. Assist with the recruitment and training of new team members. May provide leadership to team in absence of supervisor / manager / equivalent. Provide support during routine or regulatory audit. Mandatory needs: Excellent customer service skills Fluency in one or more foreign language(s) may be required Excellent written and verbal communication skills Good word processing skills Good organizational skills Basic leadership skills Attention to detail Ability to work in a fast-paced environment Ability to establish and maintain effective working relationships with coworkers, managers and clients High school diploma or educational equivalent and 3 years customer service experience; or equivalent combination of education, training and experience . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Job Overview Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. Essential Functions Acts as a Regulatory Team Leader on more complex projects, which may include technical writing; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments; Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person; May act as reviewer for regulatory standard operating procedures, as assigned and appropriate; May prepare and deliver regulatory training to IQVIA small groups or individuals; Performs other tasks or assignments, as delegated by Regulatory management; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req At least 3-4 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Job Overview Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle (startup, maintenance, closeout). Ensures work is conducted in line with standard operating procedures, policies and good practices. Essential Functions Study Setup and Planning: Facilitate seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue and action logs. Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation. Will prepare and present protocol-specific materials at Kick Off and Investigator meetings May participate in the proposal and business development process including bid defence meetings. Support development of Customer standards Study Activity Monitoring and Closeout: Will monitor the Project Management Plan, timelines and deliverables, manage study documentation throughout the Project lifecycle including filing into eTMF, oversee study monitoring and reporting, conduct meetings to meet needs of the Study and Customer requirements Will manage study scope changes and budget monitor quality of the study and any service-related issues, implementing changes as required. Lessons learnt will be reviewed and shared Proactive Lines of Communication: Build and own the Customer relationship, facilitate communication, collaborate with all operational areas within the company Will serve as an escalation point for study level issues and will coordinate and triage study-specific issues Coordinates customer survey follow up and ongoing health checks to support Customer relationship building Meetings, Initiatives and Training Activities: Will represent the company at Investigator meetings and other internal / external face to face meetings. Will participate in audits and inspections as required Will provide study training to sites, CRAs and customers Will establish regular lines of communication with sites to manage on-going project expectations and issues. Will participate in improvement projects as needed Will assist in training of less experienced staff. Qualifications Bachelors Degree Life Sciences and/or related field Pref Or Other Equivalent combination of education, training and experience may be accepted in lieu of degree. 2+ years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or Equivalent combination of education, training and experience Strong interpersonal and customer management skills. Working understanding of medical and clinical research terminology. Working knowledge of Project Management processes, the company laboratory processes, and/or equivalent working knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) preferred. Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar Centralized Laboratory systems preferred. Experience in successfully leading Phase I-IV clinical trials preferred. Demonstrated ability to work in a fast-paced environment while possessing strong organizational skills and a demonstrated ability to meet deadlines. Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred. Ability to establish and maintain effective working relationships with coworkers, managers and customers. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Job Overview Independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Essential Functions Client Management: Serve as primary point of contact for customer on data management deliverables manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies. Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise Lead direct negotiations with customer, e.g., timelines, financial, process, resources. Maintain strong customer relationships Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables provide training and development on data management expertise to junior team members Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects Serve as the escalation point for unresolved data issues independently work with client data managers, vendors, internal team members for resolution Ensure appropriate resources are assigned to meet project deliverables Create and/or review and sign-off on all data management plan (DMP) documents Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW Implement proactive quality management plans across multiple projects/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions Continuously look for opportunities to improve service develop and work with team to implement plan to re-organise and drive change (possibly across a customer account) Ensure timely follow-up and resolution of compliance issues Serve as Subject Matter Expert (SME) Provide leadership and expertise in a specific CDM task or technology Serve as customer site lead for one or more customers Train and mentor junior DTL staff in DM expertise may coordinate the work of more junior DTL staff Independently maintain internal tracking databases and systems Financial Management/Business Development Support: Independently manage SOW/budget Review financial reports on a monthly basis and participate in project reviews as requested Identify out of scope tasks and track change orders to completion Participate in pricing discussions across customer account Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing Independently support RFP process (review RFP documents, pricing, attend bid defense) Other: Independently bring process improvements and solutions to the CDM team/CDM department Lead a focus team or global or local best practice team Communicate lessons learned and/or present in CDM workshop(s) Manage the development and implementation of new technology or tool Present at professional conferences and/or publish articles in professional journals Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions Perform other duties as directed by the functional manager Qualifications Bachelors Degree Health, clinical, biological or mathematical sciences, or related field Req 5 years of direct Data Management experience with 3 or more years as a CDM project lead Pref Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients). Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and relevant regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work independently. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients). Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and relevant regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work independently. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Responsibilities: -Under general supervision, conducts mapping of SDTM and Custom domains. -Understands and reviews requirements, creates plans and/or contributes in estimations. -Performs planning, mapping domains, review domains and Unit testing on planned releases. -Supports and performs defect fix and tracking; coordinates with team. -Works closely with testers, Dev Leads/Managers and other project stakeholders. -Maintains documentation to assist in debugging and modifying software; analyzes results to ensure existing functionality and recommends corrective action. -Coordinates with testing teams in troubleshooting and resolving issues. -Regularly documents, tracks and escalates issues as appropriate. -Seeks necessary managerial support to discuss/flag risks and mitigation plans. Experience: -Individual contributor with 2-6 years of experience who works under close supervision. -Experience to create SDTM datasets of clinical data from raw data -Experience on Clinical domain is preferred. -Experience in any one of ETL tool and concepts is preferred. -Good hands on experience in Oracle/SQL. -Hands on experience in these tools - HP ALM, JIRA, Synapse RT. Education: -Bachelor s or Masters Degree in Computer Science, Information Technology, Clinical Information Management or equivalent qualifications. Knowledge: -Good Strong understanding of SDLC processes. -Good strong understanding of defect lifecycle. -Good knowledge on CDISC concepts and deliverables -Good knowledge on end to end clinical data management activities -Good Understanding on eCRF, protocol & study related documents. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

The IQVIA Global Oncology team has primary responsibility for curating anonymous patient-level data for a wide array of tumors on a global scale, analyzing the data and providing insights and recommendations to cancer care stakeholders. As a Client Service Representative in Oncology Market Research, you will be ensuring high-quality deliverables, data-driven insights, and continuous engagement to maximize client value in using our syndicated Oncology patient tracker study. You will play a pivotal role in the Global Oncology Service team, focusing on Client Support, Internal Customer Support, and Product Expertise. In this role, you will Actively acquiring and applying expertise in IQVIA proprietary databases, methodologies, and analytical frameworks to generate client deliverables and internal reports. Developpe comprehensive data analyses and delivering tailored reports to precisely address client requests. (This could be in collaboration directly with clients or with colleagues working on behalf of the clients) Ensure seamless client onboarding and enhance service delivery workflows to achieve maximum efficiency and drive client satisfaction. Diligently train clients, delivering comprehensive training materials, and conducting client workshops ( Ie: presentation of the deliverables) as needed. Conduct thorough desk research based on specific briefs, utilizing both internal and external sources to support project deliverables and enhance internal oncology knowledge. Develop expertise on our visualization tools (e.g., MicroStrategy or any other tool as relevant) to provide customized analytics to specific client needs. Strengthen support in IQVIA countries that lack Oncology expertise and client service resources. This involves delivering comprehensive training crafting detailed reports to effectively meet clients needs and ensure successful deliveries. Support commercial teams to achieve revenue and growth by providing comprehensive guidance on data usage, offering expert advice on product capabilities, and providing services prices recommendations. This includes Engage with clients through calls, showcasing the database, addressing client-specific inquiries, and evaluating feasibility for Request for Proposals. Support the internal new countries or existing IQVIA countries involved in lacking Oncology expertise and client service resources, including training, service pricing, and report creation to support clients needs and deliveries. Contribute to questionnaire enhancement and improvement by performing data validations through secondary research and collaboration with Legacy Quintiles medical teams. Work closely with our operation and product management team to Support the launch of new Oncology products/deliverables. Work closely with a diverse range of peers, project managers and subject matter experts, in offices across the world to better fulfil the need of the role. Partner on webinars organized by the OD marketing team (or other IQVIA teams if required) Maintain specialist therapeutic area knowledge through relevant literature, internet sources, conferences, IMS publications, and share it with the rest of the team. Essential Experience, Skills and Education Required: Master s/Bachelor s degree (or equivalent); preferably in physical, natural or biological science, medicine, mathematics, economics or business Experience/interest in healthcare, life sciences and the pharmaceutical industry, preferably in oncology. Knowledge of key issues and current developments in the pharmaceutical and healthcare industries Good commercial awareness/business judgment Knowledge/interest of consulting methodologies, tools, and techniques Analytical, interpretative, and problem-solving skills. Comfort in conducting analytics using multiple data sources. Attention to detail and ability to deliver high quality work within short timelines. Excellent English verbal (presentation) and written communication skills; additional languages an advantage Strong interpersonal and relationship building skills; able to build credibility with key customers and stakeholders. Ability to multi-task Strong IT literacy e.g. Word, PowerPoint, Excel; experience using MicroStrategy desired (but not critical) A willingness and ability to travel if required, but this will be very limited. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management and/or Coding activities, and may provide leadership either in the role of the Lead Coder or in a specific CDM task (e.g. Data Operations Coordinator (DOC) or lead a coding related task on a mega trial). Essential Functions 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

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle (startup, maintenance, closeout). Ensures work is conducted in line with standard operating procedures, policies and good practices. Essential Functions Study Setup and Planning: Facilitate seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue and action logs. Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation. Will prepare and present protocol-specific materials at Kick Off and Investigator meetings May participate in the proposal and business development process including bid defence meetings. Support development of Customer standards Study Activity Monitoring and Closeout: Will monitor the Project Management Plan, timelines and deliverables, manage study documentation throughout the Project lifecycle including filing into eTMF, oversee study monitoring and reporting, conduct meetings to meet needs of the Study and Customer requirements Will manage study scope changes and budget monitor quality of the study and any service-related issues, implementing changes as required. Lessons learnt will be reviewed and shared Proactive Lines of Communication: Build and own the Customer relationship, facilitate communication, collaborate with all operational areas within the company Will serve as an escalation point for study level issues and will coordinate and triage study-specific issues Coordinates customer survey follow up and ongoing health checks to support Customer relationship building Meetings, Initiatives and Training Activities: Will represent the company at Investigator meetings and other internal / external face to face meetings. Will participate in audits and inspections as required Will provide study training to sites, CRAs and customers Will establish regular lines of communication with sites to manage on-going project expectations and issues. Will participate in improvement projects as needed Will assist in training of less experienced staff. Qualifications Bachelors Degree Life Sciences and/or related field Pref Or Other Equivalent combination of education, training and experience may be accepted in lieu of degree. 2+ years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or Equivalent combination of education, training and experience Strong interpersonal and customer management skills. Working understanding of medical and clinical research terminology. Working knowledge of Project Management processes, the company laboratory processes, and/or equivalent working knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) preferred. Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar Centralized Laboratory systems preferred. Experience in successfully leading Phase I-IV clinical trials preferred. Demonstrated ability to work in a fast-paced environment while possessing strong organizational skills and a demonstrated ability to meet deadlines. Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred. Ability to establish and maintain effective working relationships with coworkers, managers and customers.

Responsibilities: -Under general supervision, conducts mapping of SDTM and Custom domains. -Understands and reviews requirements, creates plans and/or contributes in estimations. -Performs planning, mapping domains, review domains and Unit testing on planned releases. -Supports and performs defect fix and tracking; coordinates with team. -Works closely with testers, Dev Leads/Managers and other project stakeholders. -Maintains documentation to assist in debugging and modifying software; analyzes results to ensure existing functionality and recommends corrective action. -Coordinates with testing teams in troubleshooting and resolving issues. -Regularly documents, tracks and escalates issues as appropriate. -Seeks necessary managerial support to discuss/flag risks and mitigation plans. Experience: -Individual contributor with 2-6 years of experience who works under close supervision. -Experience to create SDTM datasets of clinical data from raw data -Experience on Clinical domain is preferred. -Experience in any one of ETL tool and concepts is preferred. -Good hands on experience in Oracle/SQL. -Hands on experience in these tools - HP ALM, JIRA, Synapse RT. Education: -Bachelor s or Masters Degree in Computer Science, Information Technology, Clinical Information Management or equivalent qualifications. Knowledge: -Good Strong understanding of SDLC processes. -Good strong understanding of defect lifecycle. -Good knowledge on CDISC concepts and deliverables -Good knowledge on end to end clinical data management activities -Good Understanding on eCRF, protocol & study related documents.

Join global organization with 82000+ employees around the world, as a Senior .Net Full Stack Developer based in IQVIA Bangalore .You will be part of IQVIA s world class technology team and will be involved in design, development, enhanced software programs or cloud applications or proprietary products. Experience: 5-7 years of experience in Web Application Development Responsibilities: - Design, develop, and maintain web applications using: Frontend technologies like Angular/ ReactJS, Web API (Rest API) and .NET Core. Backend technologies like SQL Server 2017, ETL/ SSIS, SSAS Familiarity in Databricks and Azure Analysis Services - Implement search functionalities using Elastic Search and optimize search performance. - Write clean, efficient, and reusable code following coding standards and best practices. - Perform unit testing and participate in code reviews to ensure high-quality deliverables. - Troubleshoot and resolve software defects and issues in a timely manner. - Work with version control systems, such as GIT & TFS, for source code management. Requirements: - Solid experience in developing web applications using: Frontend technologies like Angular/ ReactJS, Web API (Rest API) and .NET Core. Backend technologies like SQL Server 2017, ETL/ SSIS, SSAS - Proficiency in implementing search functionalities using Elastic Search. - Experience in implementing SOLID Principles.

Provides high quality, on-time input to client projects in the Market Access Analytics(aka Payer Analytics/Managed Market Analytics) with Patient level data LAAD(aka APLD, Patient Level data). Assignments range in complexity from intermediate analysis and problem solving to assisting in the development of more complex solutions. May serve as project leader for small teams or work streams. Essential Functions Assists with the review and analysis of client requirements or problems and assists in the development of proposals and client solutions. Assists in the development of detailed documentation and specifications. Performs quantitative or qualitative analyses to assist in the identification of client issues and the development of client specific solutions. Assists in the design/structure and completion of presentations that are appropriate to the characteristics or needs of the audience. Develops, and may present, complete client deliverables within known/identified frameworks and methodologies. Proactively develops a basic knowledge of consulting methodologies and the Payer Analytics space through the delivery of consulting engagements and participation in formal and informal learning opportunities. Engagement based responsibilities are assigned and managed by Senior Consultants, Engagement Managers or Principals. Qualifications Bachelors Degree Req 4-7 years of related experience Req Works willingly and effectively with others in and across the organization to accomplish team goals. Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline. Knowledge of consulting methods, tools and techniques- SQL/Python, related to one s functional area. Knowledge of US Healthcare stakeholders and their key interactions, roles and responsibilities. Knowledge and understanding of the Patient level data sets for US Healthcare.

Job Overview Provides high quality, on-time input to client projects in the Market Access Analytics(aka Payer Analytics/Managed Market Analytics) with Patient level data LAAD(aka APLD, Patient Level data). Assignments range in complexity from intermediate analysis and problem solving to assisting in the development of more complex solutions. May serve as project leader for small teams or work streams. Essential Functions Assists with the review and analysis of client requirements or problems and assists in the development of proposals and client solutions. Assists in the development of detailed documentation and specifications. Performs quantitative or qualitative analyses to assist in the identification of client issues and the development of client specific solutions. Assists in the design/structure and completion of presentations that are appropriate to the characteristics or needs of the audience. Develops, and may present, complete client deliverables within known/identified frameworks and methodologies. Proactively develops a basic knowledge of consulting methodologies and the Payer Analytics space through the delivery of consulting engagements and participation in formal and informal learning opportunities. Engagement based responsibilities are assigned and managed by Senior Consultants, Engagement Managers or Principals. Qualifications Bachelors Degree Req 4-7 years of related experience Req Works willingly and effectively with others in and across the organization to accomplish team goals. Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline. Knowledge of consulting methods, tools and techniques- SQL/Python, related to one s functional area. Knowledge of US Healthcare stakeholders and their key interactions, roles and responsibilities. Knowledge and understanding of the Patient level data sets for US Healthcare. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Description Are you excited about developing state-of-the-art Machine Learning, Natural Language Processing, designs using large data sets to solve real world problemsDo you want to build a foundation for your career after your Bachelors or Masters or Ph D program at an industry-leading companyYou enjoy the prospect of solving real-world problems that, quite frankly, have not been solved at scale anywhere before Along the way, you'll get opportunities to be a fearless disruptor, prolific innovator, and a reputed problem solver someone who truly enables machine learning to create significant impacts you will bring statistical modeling and machine learning advancements for customer-facing solutions in complex industrial settings You will be working in a fast-paced, cross-disciplinary team who are leaders in the field You will take on challenging problems, distill real requirements, and then deliver solutions that either leverage existing academic and industrial research, or utilize your own out-of-the-box pragmatic thinking In addition to coming up with novel solutions and prototypes, you may even need to deliver these to production in customer facing products Basic Qualifications Currently enrolled in degree program (Bachelors or MS/ Mtech ,MCA.) Engineering ,Computer Science, Mathematics, or related field with specialization in machine learning, NLP, ASR, deep learning, computer vision, data science or related fields. working knowledge of programming languages such as Python (SciPy, RPy2, etc). Preferred Skill NLP, Python, React, Mongo Responsibilities include: Design, Develop, Maintain ReactJS WebApp

Minimum 5+ years of experience In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.) Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc. In-depth knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus Experience utilizing tools intended for report writing, analytics, visualizations, or dashboard creation (e.g., Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI, etc.) to support ongoing clinical data and safety review

Minimum 10+ years experience with ADaM and TFL programming , Experience in Oncology studies on Efficacy ADaMs and TFLs (ADTTE - PFS, OS, DOR, BOR, ORR is must) Experience on KM Plots, waterfall plot, Forest plot is required.Phase 2,3 Preferable experience