Description
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
**Local Clinical Trial Manager**
**Live**
**What you will do**
The Local Trial Manager is a new role as part of our Next Generation Trial Execution Build. The goal is to optimize our clinical trial delivery from early to late studies.
In this important new role, you will be the primary point of contact to lead, manage, and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out (CSR/Archival) for the Netherlands per ICH-GCP (Good Clinical Practices) and other applicable local regulations.
You will maintain the quality and scientific integrity of clinical trials at the country level and actively collaborate with cross-functional internal and external partners to ensure timely delivery, and budget execution of clinical trial results within the local country.
Let’s do this. Let’s change the world. In this vital role, you will:
+ Partner with global and local country teams to provide high-level country strategy and actively drive study progress and local/country-level study delivery.
+ Planning, management, and oversight of 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 including updates to relevant systems for transparency.
+ Provides country-level input into the Country’s Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study.
+ Support internal audit and inspection activities and contribute to CAPAs, including leading the resolution of issues when appropriate e.g., 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.
+ Analyze country-specific study trends and implement improvement opportunities.
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a professional Trial Manager with these qualifications:
+ Master’s degree in medical-related field of study.
+ Outstanding knowledge of global clinical trial management.
+ 7 years of work experience in life sciences or medically related fields, including 4 years of biopharmaceutical clinical research experience acquired working on clinical trials in a biotech, pharmaceutical, or CRO company.
+ Strong communication skills in both Dutch and English.
+ Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.).
+ Country expert with proven project management experience locally.
+ Ability to build strong site relationships as well as other local relationships to ensure end-to-end study delivery is met.
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Therefore, Amgen is recognized as World’s Best Workplace 2021 ©.
+ Vast opportunities to learn and move up and across our global organization.
+ A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
+ Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance, and collective health insurance.
+ Focus on vitality with an on-site gym, a vitality program, and a restaurant with healthy food.
+ Flexible work arrangement with days in the office and working from home (remote work optional).
