ResearchEd

Senior Clinical Data Manager

ResearchEd

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • Oversee, lead, manage and provide technical expertise within the assigned projects.
  • 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.
  • Oversee data cleaning activities.
  • Produce metrics to monitor progress of trial activities.
  • Ensure all database lock activities are completed on time.
  • Represent WorldWide DM at both internal and external study meeting calls.
  • Monitor project scope, budgets and risks and alert DM Management of any concerns.
  • Liaise with DM Management regularly to discuss progress and issues outstanding.
  • Collaborate with internal Worldwide departments working on the same project.
  • Provide training, support and mentorship to other members of the DM department.

Requirements

  • Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
  • Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
  • Strong knowledge of data management best practices & technologies as applied to clinical trials.
  • Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Independent and autonomous project oversight skills.
  • Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.
Benefits
  • Health insurance
  • Professional development
  • Flexible working arrangements
Applicant Tracking System Keywords

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

Hard Skills & Tools
data managementclinical data managementdata cleaningtrial documentationvendor reconciliationmetrics productiondatabase lock activitiesproject scope managementbudget managementrisk management
Soft Skills
leadershipautonomous project oversightcollaborationmentorshipcommunication
Certifications
Bachelor’s degreebiomedical scienceslife sciencescomputer science