Clinical Trial Manager
2 semanas atrás
Amgen is seeking a highly skilled Clinical Trial Manager to lead the conduct of clinical trials from study start-up to close out at a country level in Portugal. The successful candidate will be responsible for maintaining the quality and scientific integrity of clinical trials, collaborating with cross-functional internal and external partners, and ensuring timely delivery of clinical trial results.
Key Responsibilities:
- Partner with global and local country teams to provide high-level country strategy and drive study progress and local/country-level study delivery.
- Plan, manage, and oversee clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team.
- Communicate country status, including timelines and deliverables, to key partners and update relevant systems for transparency.
- Provide country-level input into the Country Operational Plan and partner with the Development Feasibility Manager to ensure local delivery of the study.
- Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate, such as vendor management.
- Assign and lead all aspects of deliverables of study support staff and continually review country-level risk mitigation to ensure study delivers to plan.
Requirements:
- Doctorate degree or equivalent experience in a related field.
- Advanced knowledge of global clinical trial management.
- Fluency in Portuguese language and business English.
- Minimum 2-3 years' experience of leading local/regional or global teams.
- Minimum 2-3 years' clinical trial project management 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 management and oversight of external vendors, such as CROs, central labs, imaging vendors, etc.
- Must be a local/country expert with proven project management experience locally.
- Must be able to build strong site relationships as well as other local relationships to ensure end-to-end study delivery is met.
About Amgen:
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 biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
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