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.
