CLINICAL PROGRAM MANAGER - CPM - (P3390)

Clinical Program Manager – CPM – (P3390) Location: Redwood City, California Category: Clinical Development and Operations Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site Job Description The Opportunity: Clinical Program Manager (CPM) This is a unique opportunity for a Clinical Program Manager (CPM). You will be responsible for driving operational strategy across multiple trials within entire clinical programs or multiple trials across indications, and support program-level governance, timelines, and decision-making. Responsibilities Provide expert thought leadership at the discipline level on highly complex and business critical assignments and begins to develop new ideas. Lead the Clinical Study Execution Team (CSET) meetings and ensure trial timelines are met. Develop trial execution strategy and timelines across study(ies). Participate in multiple department or interdepartmental strategic initiatives under limited supervision as it relates to study-specific initiatives. May serve as a resource for others with regard to a specific study trial. Maintain audit/inspection readiness and oversee TMF compliance. Collaborate with cross functional partners in drafting study documents such as protocols, ICFs, CRFs, monitoring plans, etc. Drive consistency in processes and tools across studies. Contribute to development of RFPs and participates in selection of CROs/vendors. May be asked to train CROs, vendors, investigators, and study coordinators, as well as cross-functional partners on study requirements. Oversee CROs, vendors, and key external partners to ensure study delivery. Make recommendations to the development of study-level budget. Participate in the recruiting and hiring process. Mentor and train Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs), and Clinical Trial Assistants (CTAs). Conduct risk management, contingency, and scenario planning. Participate in other Clinical Operations activities as appropriate. Required Skills, Experience And Education BS, BA, or RN in a relevant scientific discipline. 8+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience. Expert knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures. High-level cross-functional collaboration; strategic thinking across trials and functions. Strategic thinking across clinical trials and functions with strong program-level planning and risk management. Independently apply clinical trials knowledge to problems that arise during the conduct of a study. High sense of priority and commitment to excellence in the successful execution of deliverables. Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team. Travel may be required (~25%). Preferred Skills Decision-making skills. Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS). Oncology experience, early and/or late stage, strongly preferred. Equal Opportunity Employer We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. #J-18808-Ljbffr Planet Pharma