Easter Seals Jobs

HOW MIGHT YOU DEFY IMAGINATION?

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 our 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.

LOCAL TRIAL MANAGER

LIVE

What you will do

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 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

• Plan, manage and oversight of clinical study execution in line with the global program strategy, through leadership with engagement of the cross-functional Local Study Team (LST)

• Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency

• Effectively own and bring up any issues related to delivery, timelines, or budget to study team as required

• Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management

• Compile and submit submissions to ethics committees/councils within the country/ies as well as submissions relating to other aspects country needs such as, European Union Clinical Trials Regulation (EU CTR), In Vitro Diagnostic Medical Devices Regulation (IVDR) directives etc.

• Contribute and develop program/study-specific materials (e.g., monitoring plan, study specific training documents)

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

• Implement regulatory agency inspection readiness activities /e.g., TMF review, story board generation)

• Coordinate site contracting, budgeting, insurance and payment process by supervising local support roles

• Assign and lead all aspects of deliverables of study support staff and continually review country level risk mitigation to ensure study delivers to plan

• Manage, oversee and supervise applicable vendor activities e.g., laboratories and equipment provisioning

• Accountable for site-level goal setting and study-specific deliverables as well as provide updates regarding the study budget and acquire approval for budget deviations for clinical sites (outside of range)

• Triage / tailor communication from study / local team to sites to ensure efficient and effective communication flow

• Drive site evaluation and selection process within country

WIN

What we expect of you

We 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

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.

• 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 NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

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 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.