The Project Manager has direct clinical trial management experience with either a CRO or Sponsor and an overall responsibility to supervise, co-ordinate and lead clinical trial specific activities in accordance with Sponsor and CRO SOPs, ICH-GCP requirements, and FDA and local regulations.
- Provide operational support to TCTM’s efforts in the planning, execution and reporting of clinical trials
- Maintain and negotiate vendor contracts
- Assist with proposals and bid defenses as needed
- Manage budgets and payments to investigator(s)/site(s)
- Manage Clinical personnel to conduct investigator identification, selection, training and routine monitoring
- Participate in the design and development of clinical study protocols and CRFs across a range of therapeutic areas to ensure monitoring efforts fully complement the drug development process within established timelines
- Implement clinical trials (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment), within a cross functional team and with oversight from the COO.
- Interface with the clinical operations, quality assurance, data management and finance regarding day to day activities of clinical trials.
- Contribute to the preparation and review of clinical program documents [clinical study protocol, clinical study reports (CSR) and submissions] and other study related documents assuring quality and consistency.
- Present in written and oral format: group productivity, project status and key deliverables to senior management.
- Track and report project progress with regards of timelines, recruitment and financial status
- Contribute to multidisciplinary task forces to support continuous improvement.
- Liaise with site investigators and their staff.
- Organize and facilitate project meetings related to study activities (study organization, initiation, execution and closure)
- Apply GCP expertise in implementing clinical operations for TCTM clinical studies
- This position does not require any direct site monitoring responsibilities but may perform co- monitoring as part of quality control program when specified in contract
- Review monitoring reports
- Develop, review and edit project plans (Clinical Monitoring Plan, Safety Management Plan and Communication Plan) to assure consistency with project goals
- Perform other duties as assigned or required
- Bachelor’s or Master’s degree in a related discipline
- Excellent oral and written communication, organizational and planning skills
- Thoroughness and dealing with complexity
- Ability and desire to work in a team-oriented environment
- Willing and able to travel (40%)
- A minimum of 5 years of experience in clinical development experience in a pharmaceutical or clinical research organization
- Previous clinical project manager experience in conducting and managing Phase 1-3 clinical trials
- Ability to manage multiple projects
- Proficiency with Microsoft Office Suite
To apply, please send a copy of your resume/cover letter to firstname.lastname@example.org with Project Manager as the subject.