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Remote Sr Data Coordinator, Clinical Data Management

Remote, MA 02139

Posted: 03/18/2025 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 618140 Is job remote?: Yes Country: United States

Job Description

The Sr Data Coordinator/Clinical Data Manager of Clinical Data Management should be self-driven, motivated, and have good communication skills. Ability to manage multiple (changing) priorities under tight timelines. Should have a strong understanding of end-to-end clinical data management activities in biotech, CRO, or a pharma background. Detail-oriented, able to identify issues and consistently collaborate to solve problems in a timely manner. This role primarily will perform the below tasks and may not be limited to
  • Responsible for completeness, timely delivery and quality of clinical data.
  • Oversee CRO to build database, eCRF, online screen review, edit checks, DVS, Data Management plan, CCG and overseeing review of TMF.
  • Experience working with DM vendors and CROs highly desirable.
  • Participate in user acceptance testing (UAT) of the clinical database, including edit check testing during database go-live or post-production changes due to protocol amendments/standards.
  • To work on data review with cross-function teams.
  • Work within the DM team on different studies/programs to achieve various milestones such as iDMC, internal analysis, etc.
  • May work on various tasks assigned by other data managers.
  • Contribute to content development and/or testing of department standards.
  • Execute data deliverables for all phases I -IV of clinical trials/programs as part of the clinical development group.
  • Oversee and Coordinate activities related to milestones such as DMC, PSUR, ISS etc,
  • May provide inputs to enhancements of processes and procedures within DM and may proactively participate in process changes.
Requirements:
  • Familiarity with eCOA, ePRO process is a plus.
  • Integration with IRT is a plus. 2-3 years of CDM or equivalent experience required.
  • Familiarity with different EDC systems or RAVE/Veeva is preferred.
  • Knowledge of GCP and other industry regulations is preferred.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.