Clinical Data Management

2 months ago

Bengaluru, India 2coms Full time

·        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

 



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