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Tata Consultancy Services Recruitment Notification for Clinical data management professionals. Interested & Eligible Candidates apply Now.

Job Description

TCS is Hiring For “Clinical Data Management Professionals“. Details below

Role : DM/LDM/SDTL(Study Data Team Lead)/Non CRF DM
Experience: 1-12 Years

Work Location: Mumbai / Pune / Bangalore /Hyderabad / Chennai / Delhi / NCR

Preferred Qualification:

15 years full-time education
Graduate in the relevant stream (Life Science / Pharmacy / Medicine). Domain expertise would be added advantage

For DM

Good understanding of Clinical Data Management processes and Medidata RAVE experience.
Understanding of Protocol and study documentation.
Hands-on experience working on set-up activities, third-party and SAE reconciliation, discrepancy management, and database lock.
Supporting Lead data manager in developing study metrics and study status reporting.
Well verse in creating and writing the Data Validation specification and test steps and performing UAT

For LDM

Project Management, Client Management, Stakeholder Management
Experience in managing data management deliverables. Creation/ Review of the study documents like eCRF Layout, DVR specification, Review of eCCG, DMP, and Data transfer plan. Responsible for data flow, discrepancy Management, and all other data management-related processes.
Handling third-party data reconciliation activities & Database Lock Activities

For SDTL

Maintains full understanding of protocol including study documentation
Responsible for attaining all requirements from the client for quality deliverable
Creation/Review of the study documents like eCRF Layout, DVR specification, Review of eCCG, DMP, Data transfer plan.
Handling third-party data reconciliation activities & Database Lock Activities

Non-CRF DM

The Non CRF Data Manager is responsible for identifying and defining the study specific non CRF data and handling procedures
To create and maintain the specifications, acquisition, and delivery of the non CRF data load like IXRS, PK, Laboratory, ECG etc.
To be responsible for set up and configure various data loading tools based on the transfer specifications as agreed with different external vendors
To perform reconciliation of the loaded data, identify and distribute the discrepancies to stakeholders until resolution
Proficiency in creating and maintaining Metrics, dashboard excel tools for data reporting
Strong Communication skills required as needs to interact with internal and external stakeholders
Proactively identifies and mitigates risks related to delay in delivery timeline etc.

At least 6 + years of related work experience in a clinical or pharmaceutical industry/company

Study Delivery

Provides support and training on the Clinical data management activities to TCS Data Managers for the relevant functional processes/work statements/projects – be trained and perform as a backup where required
Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise
Single point of contact for Study Data Manager/designee

Study /Project Management

Overall in charge of all Data Management activities for a study/ies including Study Set up, Conduct, and Close Out.
The primary point of contact for CDM and works are the liaison for Programmer, DAS, and coding activities too
Monitors and evaluates overall study progress, identify the potential risk/challenges faced during the course of the study
Monitor, maintain & report KPI / SLAs /metrics on the study
Performs tasks/activities as communicated by the TCS Group Leader (GL) and/or Project Manager (PM) and Study Data Manager (SDM)
Ensures adequate resources for the Study throughout its lifecycle in collaboration with the Group leader and informs (SDM and/or Alliance Manager (AM) as applicable) contact of any changes in staff
Keeps TCS Group Lead & Project Manager fully informed about the need for the resources so the resource requests can be finalized with Alliance Manager and TCS PM
Keeps record of all activities to ensure the smooth flow of the study throughout its lifecycle
Set priorities and targets of the study within the teams
Responsible for recruitment, selection, training of team members & managing attrition
Works as a mentor for DM staff assigned on the study/ies