Tata Consultancy Services is an Indian multinational information technology services and consulting company headquartered in Mumbai. It is a part of the Tata Group and operates in 149 locations across 46 countries.
Post : DM / LDM / SDTL (Study Data Team Lead) / Non CRF DM
Experience : 1- 8 Years
Work Location : Indore / Gandhinagar / Nagpur
Preferred Qualification :
• 15 years full time education
• Graduate in the relevant stream (Life Science/Pharmacy/Medicine). Domain expertise would be added advantage
Job Description
For DM
Skill :
• 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 data base 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
Responsibilities :
• Maintains full understanding of protocol including study documentation. Experience working on Setup activities, reconciliation of third-party data, SAE reconciliation, discrepancy management, freezing and locking, and archiving.
• Well verse in Writing eCRF specifications, Preparation of Protocol Deviation Document., Drafting eCRF completion guidelines., Writing DVR specifications and writing Test step, Creation of UAT plan, performing UAT. Preparing UAT report.
• Preparing Data Transfer Agreement for Vendor, Preparing and maintaining DMP Metrics
• Coordinates with the LDM, TA Lead with respect to any unresolved queries and close the same
For LDM
Skill :
• Project Management, Client Management, Stakeholder Management
• Experience in managing the data management deliverables. Creation/ Review of the study documents like eCRF Layout, DVR specification, Review of eCCG, DMP, 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
Responsibilities :
• 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
• Responsible for Timely and quality delivery of all Set-up, Conduct and close-out activities to the Client.
For SDTL
Skill :
• 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
Responsibilities :
• Responsible for Timely and quality delivery of all Set-up, Conduct and close-out activities to the Client
• Process studies and serves as primary operational contact for Study.
• Exhibits strong project management and organizational skills to monitor study progress.
• Oversee all studies assigned to reporting DMs and suggest resolutions.
• Ensure that data management activities follow global and Program level standard requirements, study timelines, ICH-GCP guidelines, Client SOPs and regulatory guidelines or regulations
• As applicable and required, attend study team meetings with DM to provide oversight support during study start up meetings as needed.
• Provide leadership inputs as and when needed during regular meetings with internal and external stakeholders responsible for the assigned study
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.
Interested candidates can share their CV to ankita.yelve@tcs.com
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