Helping Clients Create the Future TCS combines tech expertise and business intelligence to catalyze change and deliver results. Our mission is to help customers achieve their business objectives by providing innovative, best-in-class consulting, IT solutions and services and to make it a joy for all stakeholders to work with us.
TCS is hiring
EDC Programmer
Job Id : 341091
EDC -Electronic Data Capture!
Skill -EDC Programming (Veeva)
Job Location –Mumbai, Pune, Bangalore, Indore, Ahmedabad
Experience Range – 1 to 6 Years
Educational Qualification(s) Required – Graduate/Postgraduate (Any life-science/ Engineering)
Desired Candidate Profile: BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), M.SC., MASTER OF PHARMACY
Key Accountabilities
- Looking for clinical Database Developer with 1+ years of experience in eCRF build and edit checks build in Veeva studio
- 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 (eg: UAT, production, testing etc.,)
- Setup and configure user accounts for study teams.
- Setup and manage blinded and unblinded study configurations.
SDTM Programmer (6-10 years)
Job Id : 350054
Educational Qualification(s) Required – BACHELOR OF COMPUTER SCIENCE, BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc), M.SC., MASTER OF PHARMACY
Responsibilities:
• Providing support for the mapping and transformation of clinical data to CDISC SDTM standards.
• Create SDTM mappings for conversion of the data.
• Perform extraction and mapping of the data from an in-house standard to an industry standard format (SDTM).
• Create the SAS programs to convert the SI data to SDTM format.
• An understanding of all required SDTM components is essential, including the clinical domain, TDD’s, define.xml, Acrf. Programming experience with SAS is required, the ideal candidate will have a background in clinical programming in a data management setting or statistical setting. The ability to focus on customer needs, troubleshooting and providing innovative technical solutions, while adhering to standards is essential.
• Integrity check to be performed every month end and the report needs to be reviewed. Required updates to be made in the development file of the respective domain and if no update is required justification needs to be provided against each report.
• Controlled Terminology mapping to be done if there is a new Controlled terminology referring the QRS mappings standards.
• Lead and actively participate in review of SDTM conversion deliverables.
• Create and maintain process documentation as required.
• SAS programming for creation / review of SDTM domains as required.
• Create aCRF for SDTM.
• Create the Define.xml as per the study requirements
• Create the SDRG document.
• Other activities as required to support SDTM conversion and implementation of CDISC standards.
Other Responsibilities:
1. Create & Maintain process documentation as required.
2. Training of new staff in the role required.
3. To ensure that the timelines of all the deliverables are met with quality as a priority.
4. To communicate with the team members and resolve or escalate queries
CDR - Clinical Data Reviewer (Clinical Data Management) (2-4 years)
Job Id : 350056
Location: Mumbai/Pune/Bangalore/Indore/Ahmedabad
Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc), M.SC., MASTER OF PHARMACY, MASTER OF SCIENCE
Job Description:
1.To be aware and to undertake any relevant and applicable trainings around SOPs, GUI & data standards.
2.Understanding of study protocol, study tasks/activities and study milestones.
3.Review Data Validation Specifications (DVS), eCRF screens and Test scripts for edit/SAS checks, create test scripts for UAT and other activities as specified in RACI.
4.To perform Data review and discrepancy management as per RACI or as agreed with SDM/DMSPoC/ODM(Over-sight Data Manager).
5.To process, perform data load and delivery of external (vendor) data using designated tools.
6.To perform external (vendor) data reconciliation at agreed frequency in order to maintain consistency with the clinical database (e.g. InForm).
7.To escalate unresolved data discrepancies/ data trends to SDM/DMSPoC.
8.To coordinate with the programming team as appropriate regarding any database or for programming changes needed throughout the study.
9.To address & action data issues highlighted by study team as and when required.
10.To create and distribute data management metrics/Newsletter, listings and reports at an agreed frequency.
11. To conduct regular scheduled study meetings with study Study team.
12.To connect with vendor & monitor for addressing issues as agreed in RACI.
13.Perform close-out activities along with the SDM/DMSPoC, per the RACI and any applicable checklists, to produce datasets in advance of DBF (interims or final) that meets the requirements as detailed in the DMP.
14.Perform Post Database Release (DBR) activities & Pre-Database Freeze (DBF) activities as required based on discussion/agreement with SDM/DMSPoC to ensure quality data delivery.
15.To maintain in-stream archival of relevant study documents in eTMF
SDM - Study Data Manager (5-10 years)
Job Id : 347428
Job Role – Clinical Data Management -Lead Data Management (LDM)
Job Location – Mumbai, Pune, Bangalore, Indore, Ahemdabad
Experience Range – Min 2 to 10 Years of relevant experience into LDM
Educational Qualification(s) Required – B. Pharma, M.Pharma, Pharma -D, BDS
Communication – Good Communication
Study Data Manager (SDM)
- Work independently and accountable for study Data Management deliverables
- Coordinate with Biostatistician, Clinical, Medical and local study team as applicable
- Represent Data Management team at study team and cross functional study team
- Worked on all phases of Clinical Data Management – Set up, conduct and close out
- Minimum 1 yrs of experience of leading a clinical trial
- Provide training/mentoring to team members
- To work on any study specific activities assigned by Line Managers
- Draft Study timelines and must ensure all stakeholders adhere to it and escalate it whenever needed
TCS Walk-In Drive 22nd February 2025 for Life Sciences roles at TCS Gandhinagar
*Freshers not Eligible
Walk-In Date: Saturday 22nd February 2025
Time: 10 AM to 3 PM
Contact Person: Divya Amin
Location: Tata Consultancy Services Limited, Recruitment Bay Garima Park, IT and ITES SEZ, Plot no 41, Gandhinagar - 382007
Skill Details:
•Data Management Study Point of Contact (DMSPOC): To oversight the end-to-end data management activities for assigned studies.
•Study Data Manager: Experience in leading set-up, conduct and close-out studies.
•Clinical Data Reviewer: Perform data review and discrepancy management as per protocol & external reconciliation.
•eDC Programmer: Experience in eCRF build and edit checks build in Veeva studio.
•SDTM Programmer: Experience in SDTM Programming and SAS Programming.
Documents to carry:
• Updated copy of TCS Application form with Resume
• Original & photocopy of Government ID proof (Aadhar Card / Pan Card / Passport / Voter’s ID)
• 1 Passport size photo
• Degree certificate or provisional certificate
• SSC, HSC & all semester’s marksheet
FOR MORE INFO
EDC Programmer, Click Here
SDTM Programmer, Click Here
Clinical Data Reviewer, Click Here
SDM - Study Data Manager, Click Here
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