Senior CDM Trial Lead — End-to-End Data Management

MSD; United Kingdom; Vor Ort; GBP 108.000 - 169.000; Vollzeit

Zusammenfassung

MSD is seeking a CDM Trial Lead to oversee end-to-end data management for assigned studies, ensuring quality, integrity, and regulatory compliance. You will partner with TA leadership and cross-functional teams to deliver data deliverables and drive process improvements.

The role requires strong leadership of data teams, expertise in CDISC standards, and experience with eDC/eCOA systems across trial lifecycles. Excellent communication and risk-management skills are essential.

Qualifikationen

• Experience leading end-to-end data management for clinical trials.
• Ability to translate protocol into data management deliverables and tools.
• Familiarity with CDISC SDTM/ CDASH and 21 CFR Part 11 compliance.

Aufgaben

• Lead end-to-end data management for studies from start-up to database lock.
• Develop data validation and query strategies for sites and providers.
• Oversee data reconciliation across multiple sources and data types.
• Manage UAT and change control across systems and data flows.
• Ensure data standards and privacy regulations are followed.

Kenntnisse

Clinical data management

EDC systems

Data validation

CDISC standards

RBQM

Risk management

Ausbildung

Bachelor's degree or higher

Advanced degree preferred

Non-degree/associate acceptable

Tools

EDC systems

eCOA

Define-XML

Data visualization tools

Jobbeschreibung

MSD is seeking a CDM Trial Lead to oversee end-to-end data management for assigned studies, ensuring quality, integrity, and regulatory compliance. You will partner with TA leadership and cross-functional teams to deliver data deliverables and drive process improvements.

The role requires strong leadership of data teams, expertise in CDISC standards, and experience with eDC/eCOA systems across trial lifecycles. Excellent communication and risk-management skills are essential.