Local Study Operations Manager

Amgen•Warren, MO

About The Position

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. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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

Nice To Haves

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.

Responsibilities

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