Your role :

As a Data Analyst, you'll work on a project, with responsibility for:

- Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks

- Triage of Safety cases

- Oversight of data discrepancy management

- Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF

- Responsible for compiling HoS content

- Conduct the protocol amendment impact assessment and complete appropriate documentation

- Manage migration and audit trail reports

- Create slides for study-specific EDC investigator training

- Generate all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.

- Provide study specific training to data manager (DM)

- Contribute to the Data Management Plan (DMP)

- Request DTS creation and ensure DTS finalized and complete for any LSH loads

- Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)

- Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)

- Manage global and study-specific data entry conventions

- Facilitate versioning, including Unlock/audit trail review & Archival process

- Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design

- Timely communication with key stakeholders on issues and risks, including

o Brings CDR, DWA, and SD together to discuss post-production changes when identified

- Provide critical information to PL who will communicate with study team

- Log any action issues into DS Hub and resolve outstanding issues assigned to DA

- Mange assigned activities to meet milestone dates

- Ask questions to get information needed to meet end goals

- Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)

What you need

- A Graduate/Post Graduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree

- Minimum 2 years to 6 years of experience in clinical data management

- Proactively communicate ownership of studies

- Critical thinking to identify root causes and best solutions for data discrepancy management

- Confidence to have tough conversations and make challenging decisions

- Enables an environment of open and honest communication and critical thinking within DSS study team

- Influence internal team to meet timelines by holding stakeholders accountable

- Ability to work with different personalities to get the work done

- Willingness to seek out information to accomplish goal

- Proactive communication

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.