· 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