Amgen Global Clinical Program Management Senior Manager in Thousand Oaks, California
The Clinical Program Management Senior Manager- (CPM Sr. Mgr.) is a part of Global Clinical Program Management (GCPM) which plans and executes the operational aspects of clinical trials globally.
Reports to: Global Clinical Program Management Director
Supports the Global Clinical Program Management Director in overseeing the planning and execution of all studies for the program (accountable for all studies in the program if no director level present) with the following:
Global clinical program operational strategy and planning, program/study risk assessment and mitigation, and overall execution of clinical trials on time and within budget
Providing clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan providing input into product global and regional evidence generation plans (product level)
Maintaining global business relationships cross-functionally and communicating program strategy and deliverables of clinical trial programs to senior management and key stakeholders
Functional oversight of Global and Regional Clinical Trial Managers and collaboration with People and Resources Manager on performance management
Initiate and support conduct of Country Operational Landscape Assessments and Targeted Local Feasibility in collaboration with cross functional roles
Development and oversight of clinical program budgets including change control in collaboration with Therapeutic Area and Finance
Contribute operational expertise throughout protocol design sessions coordinating cross functional input on a continuous basis
Support / accountable for study global enrolment and accurate global recruitment forecasting, and implement and measure the success of subject recruitment and retention strategies
Identify outsourcing requirements at a study / program level and oversee the identification, set-up, and management of CROs and vendors; may represent GCPM at Vendor Operational Management Teams; contribute to capability assessments for new vendors and participate in vendor qualification assessments
Supports and oversees internal audit, inspection activities, contributes to CAPAs globally for the program and lead planning for regulatory agency inspection readiness activities (e.g. TMF review)
Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution ; Contribute to development and maintenance of policies, SOPs and associated documents
Facilitate sharing of best practices and product knowledge within the function
Master's Degree and 2 years of Clinical experience
Bachelor's Degree and 4 years of Clinical experience
Associate's degree and 10 years of Clinical experience
High school diploma / GED and 12 years of Clinical experience
Master’s degree in life science, computer science, business administration or related discipline
7+ years work experience in Global Clinical Trials Management
3+ years project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.)
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Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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