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