Dear Candidate,
Mandatory Skills
Hands on experience on Medidata Rave or Oracle Inform platform (priority to Medidata Rave), hands on experience on at least 2 of the 3 phases of Clinical Data Management (start up/ set up, conduct, close out)
Purpose of the role:
Individual Accountabilities
Parameters for Success
- 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
- 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
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)
Strive for:
- 10-day database lock
- 0 unlocks
- 0 document rejections
- 0 post-production changes
- 0 escalation from study team to TA Lead or Global Head
Deliver:
- HOS slides
- Meeting committed timelines
- Highest-quality clinical data
- Highest-quality documentation
Operational:
Key Behaviors
- 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
Decision Rights
(D=Decision Maker, A=Advice Giver, I=Informed Stakeholder)
Data Management Processes (A)
DS Deliverable Timelines (I)
Prioritize Workload (I)
Study Timeline (I)
Stakeholders
Primary
Bioanalysis
CDR
CDSM
Clinical
DM
Document Management
DS SMEs (DTS, Labs, IRT, etc.)
DWA
Interface Designer
LSO
Medical Coding
Medical Monitor
OST
PL
QL
Randomization Personnel
Safety Management
SD
Site Management and Monitoring
Stats/Stats Programming
Tester
Vendors
Secondary
CRF Processing
Data Standards Analyst
Medical Writing
PV
TA Lead