Worldwide Clinical Trials
As a leading full-service global CRO, we work to create solutions that advance new treatments from discovery to reality.
Senior Clinical Data Manager
Location
North Carolina
Posted
31 days ago
Salary
Not specified
Bachelor Degree5 yrs expEnglish
Job Description
• Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs
• Ensure appropriate resources are allocated to complete all DM activities on time and budget.
• Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
• Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).
• Monitor project scope, budgets and risks and alert DM Management of any concerns.
• Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g. during Project Review Meetings).
• Collaborate with internal Worldwide departments working on the same project.
• Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings.
Job Requirements
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience
- Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
Benefits
- Diverse and inclusive environment
- Professional development opportunities