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Location

Uxbridge, Greater London | United Kingdom

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Job description

Career Category

Clinical

Job Description

Local Trial Manager (LTM)

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out (CSR/Archival) at a country level in accordance with ICH-GCP and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials 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:

• 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 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 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Trial Manager with these qualifications.

Requirements

• BA/BS/BSc or Phd
• Experience of leading local/regional or global teams within a Biotech, Pharmaceutical or CRO company.
• Clinical trial project management experience
• Extensive work experience in biopharmaceutical clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company or in life sciences or medically related field
• Experience in management and oversight of external vendors (e.g., 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.

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen 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 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 accommodation.

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About Us

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. 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.

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