Clinical Project Manager
United States
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Job Description
TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.
We are seeking a highly motivated Clinical Project Manager for our growing organization!
At TKL, the Clinical Project Manager independently manages multi-center clinical trials. Takes ownership of projects to assure proper planning, timely initiation/completion and high quality documentation. Provides key coordination role with the Sponsor, vendors, sites, CRAs, Recruitment Management, Quality Assurance, Data Management, Biostatistics, and Medical Writing departments.
Responsibilities include, but are not limited to:
- Participates in Bid Defense and Capabilities Meetings as required.
- Manages all activities related to multi-center trials for assigned projects.
- Communicates with the internal project team and sponsor project team.
- Maintains and is accountable for study timelines and communicates changes internally and with the sponsor.
- Utilizes project metrics and ensures staff understands their role, functional areas and takes ownership to drive results.
- Ensures roles and responsibilities are clear across internal and external organizations to achieve desired results.
- Oversees site feasibility and selection process and consults with the sponsor on the final site list.
- Negotiates investigative site budgets.
- Responsible for implementation and compliance to key contract provisions while informing management and client for out of scope activities.
- Reviews and approves Case Report Forms and source document template.
- Plans, manages, and presents at investigators’ meetings.
- Conducts team meetings (approves agenda and reviews minutes).
- Collaborates and works closely with Lead CRA and/or CRA Manager and provides appropriate feedback to Director, Monitoring.
- Accountability to tracking study budgets.
Skills/Requirements
Min Bachelor’s degree, preferably in the sciences or health related field. Advanced degree is a plus. The ideal candidate will have at least 7 years of clinical trials experience in Project Management with a clinical research organization. Must also possess detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. Strong computer proficiency with MS Office, strong organization skills, detail orientation and good communication skills are required. We are considering both office and remote-based candidates for this opening. If remote, home office experience is required. This is a full-time position.
We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.
