Data Quality Lead (Clinical Trials)
- Stevenage, Hertfordshire (GBR)
- £550 - £600 Per Day
- 12 Months
- Start date: 31 Aug 22
- Ref: GSK0JP00096368
- clinical trials
- data management
- medical devices
Data Quality Lead (Clinical Trials)
12 Months
£600p/d Max via Umbrella
4 Days per Week
Stevenage
Develop and deliver end-to-end clinical data management in early clinical studies that establish portfolio of evidence supporting pivotal trials of medical device(s) for immunomodulation therapies. Position will work in a small company environment with cross-function teams, external investigators, Contract Research Organizations, and Core and Biomarker Laboratories
Responsibilities
• Lead and manage end-to-end clinical data management across Galvani projects including;
o Electronic Case Report Form design and other clinical outcomes assessments
o Defining and executing the Data Management Strategy including data ingestion, cleaning, and reconciliation
o Interim and final cleaned database lock
o Archival of all DM documents in the eTMF
o Archival of the study database and provision of clinical data to the study site
o resource management
• Develop study data management plans and documentation in accordance with SOPs and WIs to deliver high quality, timely data deliverables to support study reporting and regulatory submissions/updates.
• Ensure appropriate oversight of database development and data management at a CRO, including budget management, consistency in data standards across projects and studies, and lead deliverables
• Creates study level timelines for DM deliverables
• Lead interim data reviews and study progress reviews at study team meetings
• Oversee and administer clinical data/document management systems including oversight of system access and management data transfers/uploads from internal and external sources including DSMB reports, central laboratory, biomarkers, imaging, device logs and clinical data archiving
• Train personnel on associated data / document management systems
• Ensure appropriate licensing is in place for PROs/COAs and clinical dictionaries
• Develop and manage relationships with key stakeholders e.g., CRO, Clinical Operations, Medical Monitor, Project Leader, Statistics, Field Clinical Engineers
• Work closely with Clinical Operations personnel to maintain the company’s electronic Trial Master File (Veeva vault eTMF), which may require risk assessment of periodic release features, user acceptance testing of configuration changes, quality checking of study file completeness, study level access management
• Participate in project teams for planning, executing, and managing the operations of complex, data intensive clinical studies, including input and review of clinical study documentation (protocol, procedures manuals, clinical study reports, charters, Monitoring plan, etc.)
• Participate in DSMB closed sessions
May lead or assist clinical risk management process within study teams during lifetime of the study and liaise with Device Risk Management lead to ensure appropriate clinical mitigations are applied
