Job Description

Career Category ClinicalHOW MIGHT YOU DEFY IMAGINATION?If you feel like youxe2x80x99re part of something bigger, itxe2x80x99s because you are. At Amgen our shared missionxe2x80x94to serve patientsxe2x80x94drives all that we do. It is key to our becoming one of the worldxe2x80x99s leading biotechnology companies. We are global collaborators who achieve togetherxe2x80x94researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Itxe2x80x99s time for a career you can be proud of. Join us.LOCAL TRIAL MANAGERLIVEWhat you will doIn this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials (CT) from study start-up to close out, at a country level in accordance with ICH-GCP and other applicable local regulations.You will maintain the quality and scientific integrity of CT at a local/country level and actively collaborate with cross functional internal and external partners to ensure timely delivery, budget execution of clinical trial results within the local country.Key Activities:

• Lead country-level study planning and execution in alignment with global strategy and monitor study progress, timelines, and deliverables
• Communicate country status to key stakeholders and update relevant systems as well as escalate issues related to delivery, timelines, or budget as needed
• Prepare and submit ethics and regulatory documents (e.g., EU CTR, IVDR)
• Support audits/inspections, lead CAPAs, and implement inspection readiness activities like TMF reviews
• Drive and coordinate site selection, evaluation, contracting and budgeting
• Maintain site relationships and conduct on-site visits with CRAs when needed
• Oversee vendor activities and local study support staff
• Track and manage country-level study budget, approve deviations, and supervise payments
• Lead study-specific deliverables and risk mitigation efforts

WINWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Degree educated
• Experience of leading local/regional or global teams within a Biotech, Pharmaceutical or CRO company.
• Work experience in biopharmaceutical clinical research acquired working on clinical trials
• Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
• Local/country expert with proven clinical trial project management experience
• Able to build strong site relationships as well as other local relationships to ensure end to end study delivery is met

THRIVEWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammatesxe2x80x99 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 health, finance and wealth, work/life balance, and career benefits

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.APPLY NOWfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation..

Amgen