Clinical Data Management

1 week ago

India 2coms Full time
Job Description

· 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

Requirements
A Graduate/Post Graduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree · Minimum 4 years to 10 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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