Amgen Global Clinical Program Mgt Senior Manager in Thousand Oaks, California
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Global Clinical Program Management (GCPM) - GCPM plans and executes the operational aspects of clinical trials globally.
Reporting to the Clinical Program Management Senior Manager- (CPM Sr. Mgr.), will be the Global Clinical Trial manager (GCTM).
A global role within GDO based at either US or UK GDO management locations
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)
Global clinical program operational strategy, planning, risk assessment and mitigation, and overall clinical trial execution on time and within budget
Providing clinical operations leadership and expertise on the Evidence Generation Team (EGT) in development of the Evidence Generation Plan (EGP) and provide operations leadership and expertise in EGP execution through the feasibility and study design process
Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management and oversight of study/ team issue escalation
Functional oversight of GCTM and RCTM, collaborates with People and Resources Manager (PRM) on performance management
Identify outsourcing requirements at a study / program level and oversee the identification, set-up, and management of CROs and vendors
Contribute to capability assessments for new vendors and in vendor evaluation, qualification, and management may represent GCPM at Operational Management Teams (OMT)
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)
Initiate and support conduct of Country Operational Landscape Assessments and Targeted Local Feasibility (if required) in collaboration with Development Feasibility Manager
Support / Accountable for study global enrolment and accurate global recruitment forecasting, and implement and measure the success of Subject Recruitment and Retention Strategies
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.)
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.