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Remote Sr Data Coordinator, Clinical Data Management
Remote , 4th Floor Remote, MA 02139 US
Job Description
- 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.
- 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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