The Clinical Project Manager (CPM) is responsible for the planning, execution, and management of clinical research studies in adherence with GCP and all applicable regulations and guidelines. Develops credible relationships with opinion leaders, sites, and clinical investigators. Acts as a liaison between AlloSource third-party vendors, CRO’s, labs, and IRB’s. Responsible for managing all project deliverables in accordance with established timelines and budgets. Contributes to the development of protocols, relevant study documents, clinical study reports, publications, and leads a clinical team.
Essential Duties and Responsibilities:
- Leads study team comprised of internal clinical staff, CRO’s vendors, and consultants, to develop, execute, and meet project timelines, budgets and deliverables in accordance with the clinical plan.
- Contributes to and authors clinical study documents, including but not limited to, protocols, informed consent form, case report forms, clinical study reports, and publications.
- Responsible for the oversight of the identification and selection process of investigator sites.
- Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments.
- Collaborates cross functionally across the organization to achieve corporate goals.
- Develops credible relationships with opinion leaders, sites, and clinical investigators.
- Leads, influences, and project manages multiple studies that deliver positive patient and investigator site experiences and quality data.
- Develops and maintains clinical research operating processes, policies, and procedures in support of regulatory compliance.
- May travel up to 50% of the time.
- Bachelor’s degree or Nursing degree
- 5 years’ clinical trial experience within an FDA regulated industry, specifically tissue banking, medical device, biologics or pharmaceuticals.
- 2 years’ project management and/or supervisory experience
- Experience working with cross-functional teams.
- Certified Project Management Professional (PMP)
- Clinical Trial Certification (CCRA, CCRC, CRP)
- Direct experience with all aspects of Clinical Trial Management, and
- Indirect experience with related business functions (regulatory affairs, operations/manufacturing, research & development, marketing & sales)
For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
Equal Opportunity Employer/Veterans/Disability
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