Director of Clinical Trial Management (DCTM) or Senior Director of Clinical Trial Management (Sr. DCTM)

Job Title : Director to Senior Director of Clinical Trial Management

Job Type : Contract (Duration : 6 moths, Temp to Perm)

Job Summary :

This is a full-time position required to work at PeproMene’s office located in Irvine, California, reporting directly to the Chief Operating Officer.

The main job duty is to manage the activities of varies regulatory and clinical projects to achieve the Company’s pipeline development goals.

Responsibilities include day-to-day coordination of project operations, program support and other management associated tasks related to drug development.

Job Descriptions :

• Day-to-day management of schedules, budgets, resources, risks, and vendors for multiple projects including clinical CRO, central labs and CDMO.
• Developing and maintaining project timelines to ensure on-time project deliverables to meet the Company’s goals.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
• Ensuring effective budget management, exhibiting close control of spend and accurate forecasting of clinical trials.
• Scheduling and managing the cross functional team meetings including preparation of agenda and minutes, tracking action items and monitoring the performance metrics.
• Collecting and compiling information from relevant parties to facilitate the communication between internal team members and external parties.
• Identifying risks and manage their appropriate response and strategies, escalating to leadership as appropriate,
• Vendor management per associated project contracts, including attending meetings, requesting, and reviewing technical information / quotes / proposals and executing tasks to meet quality / timeline / budget.
• Preparing presentations as requested by the management team.
• Performing other assigned tasks as necessary and as directed.
• Required to occasionally work at non-regular business hours.
• Must be able to participate in cross-functional strategic initiatives under limited supervision

Education and Skills Required :

• Master's degree in a scientific discipline with a minimum of 6 years of relevant industry experience.
• Experience in Clinical Trial Management required.
• Experience in Oncology or Cell Therapy drug development required.
• Experience in managing CDMO projects preferred.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Excellent written and verbal communication skills.
• Must be proficient in Microsoft Office, especially MS Word, Excel and ppt.
• Motivated to work effectively in a fast-paced environment and handle multiple projects.
• Detail-oriented, organized, and a team player.
1 day ago