Worldwide Clinical Trials

Senior Clinical Data Manager

Worldwide Clinical Trials

full-time

Posted on:

Location Type: Remote

Location: North Carolina • United States

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Job Level

Senior

About the role

  • 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.

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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data managementtrial documentationprogramming reconciliationbudget managementrisk monitoringvendor reconciliationedit check specificationsdatabase specificationsclinical data managementproject management
Soft Skills
leadershipcommunicationcollaborationproblem-solvingorganizational skillsautonomyinterpersonal skillsattention to detailtime managementadaptability
Certifications
Nursing qualificationdegree in Life Scienceclinical data management certificationproject management certificationregulatory affairs certificationGood Clinical Practice (GCP) certificationISO 9001 certificationClinical Research Associate (CRA) certificationCertified Clinical Data Manager (CCDM)Certified Clinical Research Coordinator (CCRC)