DIRECTOR OF CLINICAL TRIAL MANAGEMENT OR SENIOR DIRECTOR OF CLINICAL TRIAL MANAGEMENT

Company: Pepromene Bio
Location: Irvine
Posted on: September 30, 2024

Job Description:

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.

Keywords: Pepromene Bio, Irvine , DIRECTOR OF CLINICAL TRIAL MANAGEMENT OR SENIOR DIRECTOR OF CLINICAL TRIAL MANAGEMENT , Executive , Irvine, California