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Local Trial Manager
vor 3 Monaten
HOW MIGHT YOU DEFY IMAGINATION?
You've earned your degree.
How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have.
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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Local Trial Manager (M/F/d)
Location Vienna
A Local Trial Manager at Amgen manages and oversees local clinical trials, ensuring that they are conducted in compliance with protocol and regulatory requirements.
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 (COLA) 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
- 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 Trial Managers (GTMs) 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, 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
- Master's degree & 3 years of directly related experience OR
- Bachelor's degree & 5 years of directly related experience OR
- Associate's 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 tria
