Job Summary:

  • 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.

Major Responsibilities:

  • 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

Qualifications

  • 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 pqueen@totalcro.com with Project Manager as the subject