Local Trial Manager
Local Trial Manager
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Job Description
Career Category
ClinicalJob Description
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering everbetter products that reach over 10 million patients worldwide. Its 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 coordinate the conduct of clinical trials (CT) from study startup to close out at a country level in accordance with ICHGCP 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 of clinical trial results within the local country.
Key Activities:
- Lead countrylevel study planning and 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 onsite visits with CRAs when needed
- Oversee vendor activities and local study support staff
- Track and manage countrylevel study budget approve deviations and supervise payments
- Lead studyspecific deliverables and risk mitigation efforts
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 wellbeing.
- 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.
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.
.Required Experience:
Manager
Employment Type
Full-Time
