Lead Data Management
TCS
5 - 10 years
Mumbai
Posted: 20/05/2025
Job Description
- Work independently ,accountable for study DM deliverables, which include activities beyond DM direct control (e.g., all activities required in biostatistics, safety, clinical research and clinical laboratory functions to achieve database freeze),as the single point of accountability for DM deliverables at a study level.
- Provide inputs to Protocol development,eCRF screen to ensure it is fit for purpose and add validation checks, create and/or provide inputs to study set-up, conduct and close-out documents e.g.Electronic Case Report Form (eCRF) Completion guidelines, Data Management Plan (DMP), Investigator /Monitor meeting materials, Data Transfer Agreement(s) (DTAs) etc.
- Leads Task Initiation Meetings (TIM),Kick of meetings, Protocol development as and when applicable and drives discussion for development of CRF (electronic and/or paper), CRF/Vendor specifications, screen review meetings where applicable, User Acceptance Testing (UAT), consolidate feedback and ensures appropriate cascade and action.
- Represent Data Management at Study Team meetings and cross functional study team meetings by taking ownership of topics and driving issues through resolution e.g. monitor meetings, external vendors.
- Provide inputs to protocol amendments, review and lead post go live changes to the eCRF, as appropriate.
- Perform the specific activities are per the RACI.
- Support SDTM related task as per study requirement.
- Provides data quality feedback to site staff and monitors and identifies re-training needs.
- Ensures timely escalation of study issues to relevant stakeholders along with solution-oriented recommendations.
- Work closely with study team to meet study milestones.
- Ensure clinical data within eCRF and vendor/external data meets quality defined in DMP to lock and freeze forms for statistical review, interim review, and/or final database lock while following the steps outlined in the DM checklist and Database close-out plan(as applicable per the study).
- Perform Post Database Release (DBR) activities & Pre Database Freeze (DBF) activities as required based on discussion/agreement with DMSPoC archival of relevant study documents to eTMF (electronic Trial Master File) as appropriate.
- Lead creation and/or updates to training material as needed on DM activities following established processes.
- To work on study specific activities assigned by DMSPoC based on study requirements.
- Highlight risk along with mitigation in study calls.
About Company
Tata Consultancy Services (TCS) is one of the largest multinational IT services and consulting companies in the world, headquartered in Mumbai, India. It operates in over 50 countries and is a part of the Tata Group, India's largest business conglomerate. TCS offers a wide range of services including software development, consulting, digital transformation, and business solutions, serving industries such as finance, healthcare, retail, and telecommunications. Known for its global reach, technological expertise, and innovation, TCS is consistently ranked among the top IT services companies globally.
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