Local Study Operations Manager

Local Trial Manager/Local Study OperationsMgr(LTM/LSOM)

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What youwill do

Let’sdo this.Let’schange 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 closeout ata country levelin accordance withICH-GCP and other applicable local regulations. You willmaintainthe quality and scientific integrity of clinical trials at a local/country level and actively collaborate with cross functional internal and external partners to ensuretimelydelivery, 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 andsubmittingsubmissions to ethics committees/councils within the country/iesas 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 withincountry

• Planning, management, and oversight of clinical study executionin accordance withthe 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,overseeand supervise applicable vendor activities e.g., laboratories and equipment provisioning

• Utilize local/country regulatory knowledge to contribute to NAMP provisioning and import/exportlicenseprocesses

• 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

• Identifyandfacilitateresolution of cross-functional study-specific issues

• Provide updatesregardingthe 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 asrequired

• Conduct on-site quality visits with CRAs where/whenappropriateand 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 whenappropriate 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 expectofyou

We are all different, yet we all use our unique contributions to serve patients. The qualified professional weseekis a Trial Manager with these qualifications. 

MinimumRequirements

• Doctorate degree OR

• Master’s degree & 3 years ofdirectly relatedexperience OR

• Bachelor’s degree & 5 years ofdirectly relatedexperience OR

• Associate’s degree & 10 years ofdirectly relatedexperience OR

• High school diploma / GED & 12 years ofdirectly relatedexperience

• 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 ensureend to endstudy delivery is met.