Local Study Operations Mgr at Amgen

Career Category

Clinical

Job Description Local Trial Manager/Local Study Operations Mgr (LTM/LSOM)

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 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
• Responsible for compiling and submitting 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.
• 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 cross-functional Local Study Team (LST)
• Contribute and develop program/study-specific 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 site-level goal setting and study-specific 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).
• Manage, supervise, and review country and study trends
• Identify and facilitate resolution of cross-functional study-specific 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 on-site 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 cross-functional 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
• Provide input into potential site list as part of FIRE process
• 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. 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 2-3 years’ experience of leading local/regional or global teams
• Minimum 2-3 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.

.