Amgen Jobs

Mobile Amgen Logo

Job Information

Amgen Clinical Trial Oversight Manager (CTOM) in Breda, Netherlands

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. Join us as :

Clinical Trial Oversight Manager

At Amgen Breda, medicines are labeled, assembled, stored, and eventually shipped to various countries worldwide. Every day more than 1000 people from 38 different nationalities are working on supply chain processes, manufacturing, marketing, and sales of our medicines and clinical research into new medicines.

LIVE

What you will do

As a Clinical Trial Mgr, you will represent the local functional management team within Global Study Operations Site Management (GSO-SM), maintaining an effective collaborative partnership with all stakeholders and ensuring the overall quality of work performed by SM-FSP staff (eg CRAs, CTAs) in support of Amgen-sponsored clinical trials.

Besides that, you will lead and manage contract responsibilities for Amgen-sponsored and investigator-sponsored clinical trials. The Clinical Trial Mgr will be also the primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, and performance management including the identification, escalation, and resolution of quality and delivery issues.

Are you ready for this new challenge? Let’s do this!

In this vital role, you will :

  • Perform sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.

  • Collaborate closely with SM-FSP Line Manager (FSPLM) to ensure an appropriate level of staff oversight is deployed.

  • Support SM-FSP staff onboarding and training, and supervise staff involved in local site contracting and budget management, insurance, and payment process.

  • Manage SCBA onboarding and training.

  • Be a point of escalation for all stakeholders to support the resolution of issues eg quality, staff turnover, and performance concerns.

  • Work with SM-FSP vendor(s) to ensure timely and appropriate planning, resource, and capacity management from study start-up to close-out.

  • Conduct on-site quality visits with CRAs where/when appropriate and support the maintenance of Amgen investigator site relationships.

  • Support inspection readiness, local country, and site level audits, and regulatory inspections when applicable including CAPA resolution.

  • Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.

  • Be involved in local and global site management and cross-functional stakeholder collaboration.

  • Actively participates in role forums including local and global functional and cross-functional initiatives.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Clinical Trial Mgr professional we seek is a collaborative effective communicator with these qualifications:

  • PhD or Master’s degree or BA/BS/BSc or qualified nurse (RN).

  • Previous experience in Life Sciences or Medically related fields (biopharmaceutical clinical research experience).

  • Previous Clinical Site Management experience.

  • Preferably previous experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry.

  • Experience in a project leadership role

  • Experience working with or for Functional Service Providers or Contract Research Organizations.

  • Supervisory Experience.

  • Knowledge of or work experience with a biopharmaceutical GRDCA or QC department.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization.

  • 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.

DirectEmployers