Position Title: Project Manager
Reports To: Vice President, Clinical Operations
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
SOPs specific to job description:
· All Administration SOPs
· All Regulatory SOPs
· All Training SOPs
· All Clinical Operation SOPs
· All General SOPs
· All Information Technology SOPs
If you are interested in applying for this job, please email your resume to firstname.lastname@example.org.