Local Trial Manager
Local Trial Manager
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Job Description
Career Category
ClinicalJob Description
HOW MIGHT YOU DEFY IMAGINATION
Youve earned your degree. How will you use that achievement to reach your goals Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Local Trial Manager (LTM)
Live
What you will do
Lets do this. Lets change the world. In this vital role you will be the primary point of contact to lead manage and coordinate the conduct of clinical trials from study startup (COLA) to close out (CSR/Archival) at a country level in accordance with ICHGCP 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
- Accountable for study results and drives key decisions within country
- Planning management and oversight of clinical study execution in accordance with the global program strategy through leadership with engagement of the crossfunctional Local Study Team (LST)
- Contribute and develop program/studyspecific materials e.g. monitoring plan study specific training documents.
- Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable agenda driven present at meetings when needed
- Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency
- Accountable for sitelevel goal setting and studyspecific deliverables for clinical sites within their country(ies)
- Manage oversee and supervise applicable vendor activities e.g. laboratories and equipment provisioning
- Utilize local/country regulatory knowledge to contribute to NAMP provisioning and import/export license processes
- Actively engage and lead local cluster team with LOC from a study perspective (e.g. Local Medical DOM).
- Provides country level input into the Country Operational Plan (COP) and partner with the Development Feasibility Manager through feasibility and with the Global Clinical Managers (GCMs) to ensure local delivery of the study
- Manage supervise and review country and study trends
- Identify and facilitate resolution of crossfunctional studyspecific issues
- Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
- Effectively own and bring up any issues related to delivery timelines or budget to study team as required
- Conduct onsite quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
- Implement regulatory agency inspection readiness activities (e.g. TMF review story board generation)
- Support internal audit and inspection activities and contribute to CAPAs including leading resolution of issues when appropriate e.g. vendor management
- Participate in crossfunctional task forces/process improvement groups
- Assign and lead all aspects of deliverables of study support staff e.g. Study Management Associate CTS SASM (Snr. Assc. Study management)
- Coordinate site contracting budgeting insurance and payment process by supervising local support roles
- Lead and continually review country level risk mitigation activities to ensure study delivers to plan
- Maintain relevant therapeutic knowledge
- Triage / tailor communication from study / local team to sites to ensure efficient and effective communication flow
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.
Minimum Requirements
- Doctorate degree OR
- Masters degree & 3 years of directly related experience OR
- Bachelors degree & 5 years of directly related experience OR
- Associates degree & 10 years of directly related experience OR
- High school diploma / GED & 12 years of directly related experience
- Advanced knowledge of global clinical trial management
Preferred Requirements
- BA/BS/BSc
- Minimum 23 years experience of leading local/regional or global teams
- Minimum 23 years clinical trial project management experience
- 7 years work experience in life sciences or medically related field including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech pharmaceutical or CRO company
- 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 wellbeing.
- Full support and careerdevelopment 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 Plancomprising health finance and wealth work/life balance and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief practice or observance. Such accommodation may not pose an undue hardship to Amgen its operations or its staff.
.Required Experience:
Manager
Employment Type
Full-Time
