Amgen Global Clinical Trial 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.
The Global Clinical Trial Manager is the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP.
Oversee the quality and scientific integrity of clinical operations for studies at a global level
Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
Lead the Clinical Study Team to drive effective decision making
Plan and manage the reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
Management of study budget and timelines
Management of vendors to the required standards
5% travel to support the execution of clinical studies
Master’s degree and 3 years of clinical experience
Bachelor’s degree and 5 years of clinical experience
Associate’s degree and 10 years of clinical experience
High school diploma / GED and 12 years of clinical experience
7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
Experience of collaborating and leading cross-functional teams in a matrix environment
Experience of working internationally
Experience of managing complex projects across multiple countries and time zones
Experience of anticipating and resolving problems
Evidence of excellent interpersonal skills