Local Study Operations Manager

April 27, 2026 Auto Import

<h2>Career Category</h2>Clinical<h2></h2><h2>Job Description</h2><div><div></div><div>Local Trial Manager/Local Study Operations Mgr (LTM/LSOM) </div><div>Live </div><div>What you will do </div><div>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. </div><div>Key Activities: </div><div><ul><li>Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery </li></ul></div><div><ul><li>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. </li></ul></div><div><ul><li>Accountable for study results and drives key decisions within country </li></ul></div><div><ul><li>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) </li></ul></div><div><ul><li>Contribute and develop program/study-specific materials – e.g., monitoring plan, study specific training documents. </li></ul></div><div><ul><li>Support and contribute to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings when needed </li></ul></div><div><ul><li>Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency </li></ul></div><div><ul><li>Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies) </li></ul></div><div><ul><li>Manage, oversee and supervise applicable vendor activities e.g., laboratories and equipment provisioning </li></ul></div><div><ul><li>Utilize local/country regulatory knowledge to contribute to NAMP provisioning and import/export license processes </li></ul></div><div><ul><li>Actively engage and lead local cluster team with LOC from a study perspective (e.g., Local Medical, DOM). </li></ul></div><div><ul><li>Manage, supervise, and review country and study trends </li></ul></div><div><ul><li>Identify and facilitate resolution of cross-functional study-specific issues </li></ul></div></div><div><div><ul><li>Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range) </li></ul></div><div><ul><li>Effectively own and bring up any issues related to delivery, timelines, or budget to study team as required </li></ul></div><div><ul><li>Conduct on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships </li></ul></div><div><ul><li>Implement regulatory agency inspection readiness activities (e.g., TMF review, story board generation) </li></ul></div><div><ul><li>Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management </li></ul></div><div><ul><li>Participate in cross-functional task forces/process improvement groups </li></ul></div><div><ul><li>Assign and lead all aspects of deliverables of study support staff e.g., Study Management Associate, SASM (Snr. Assc. Study management) </li></ul></div><div><ul><li>Coordinate site contracting, budgeting, insurance and payment process by supervising local support roles </li></ul></div><div><ul><li>Lead and continually review country level risk mitigation activities to ensure study delivers to plan </li></ul></div><div><ul><li>Maintain relevant therapeutic knowledge </li></ul></div><div><ul><li>Triage / tailor communication from study / local team to sites to ensure efficient and effective communication flow </li></ul></div><div><ul><li>Provide input into potential site list as part of FIRE process </li></ul></div><div><ul><li>Drive site evaluation and selection process within country </li></ul></div><div> </div><div>Win </div><div>What we expect of you </div><div>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. </div><div>Minimum Requirements </div><div><ul><li>Doctorate degree OR </li></ul></div><div><ul><li>Master’s degree & 3 years of directly related experience OR </li></ul></div></div><div><div><ul><li>Bachelor’s degree & 5 years of directly related experience OR </li></ul></div><div><ul><li>Associate’s degree & 10 years of directly related experience OR </li></ul></div><div><ul><li>High school diploma / GED & 12 years of directly related experience </li></ul></div><div><ul><li>Advanced knowledge of global clinical trial management </li></ul></div><div>Preferred Requirements </div><div><ul><li>BA/BS/BSc </li></ul></div><div><ul><li>Minimum 2-3 years’ experience of leading local/regional or global teams </li></ul></div><div><ul><li>Minimum 2-3 years’ clinical trial project management experience </li></ul></div><div><ul><li>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 </li></ul></div><div><ul><li>Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) </li></ul></div><div><ul><li>Must be a local/country expert with proven project management experience locally </li></ul></div><div><ul><li>Must be able to build strong site relationships as well as other local relationships to ensure end to end study delivery is met. </li></ul></div><div></div></div><div> </div>.

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