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Clinical Program Coordinator
Job Opportunity at
Clinical Dynamix, Inc.
Posted on Jul 10
Clinical/Sr. Clinical Program Coordinator (Contract)
The Clinical/Sr. Clinical Program Coordinator is responsible for supporting the clinical development operations team across multiple clinical studies and programs, as well as clinical development operations department-wide activities and initiatives.
Study team and department support
QC study documents
Coordinate sponsor team review and finalization of key study documents
Support study team during key deliverable milestones
Meeting logistics, documentation, and follow-up
Support financial management activities
Develop trackers and presentations for department in support of key projects, i.e. stakeholder communications
Document management / TMF SME and support (Department and study / program level)
Department, Program and Study Level:
SME for study document management
Lead implementation of eArchive, including related process development
Evaluate, develop and maintain TMF process documentation including creation of TMF Review Plans, review of study and program indexes, development of tools for documenting Sponsor TMF review / oversight
Coordinate and conduct TMF reviews with study personnel according to TMF Plans
Liaise with CRO TMF personnel and eArchive vendor
Communicate TMF-related updates and issues to clinical operations leads and work with vendors to address findings through resolution / closure
Load documentation to share folder / eArchive
Ensure complete and inspection ready eTMFs throughout the duration of clinical trials
Vendor, contract and budget support
Assist contract manager and study / program operations leads in tracking contract spend and values
Vendor communications; may also assume direct vendor management
Support vendor selection and ongoing vendor performance evaluations
At least 5 years of experience supporting clinical trials administratively or as a study coordinator; experience with a pharmaceutical or biotech company is preferred; additional experience in other related fields or positions is a plus.
BA/BS in a clinical or scientific discipline preferred; can be substituted with more years of experience.
Savvy with IT systems including standard MS software applications.
Good general GCP knowledge.
Excellent interpersonal, organization, problem solving, and communication skills.
Working collaboratively and proactively with a “can-do” attitude.
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