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

Full TimeRemoteTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

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

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