Position Title: Project Manager

Reports To: Vice President, Clinical Operations

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

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 bizdev@totalcro.com.