Director, Local Study Operations Manager
About The Position
The Local Study Operations Manager (LSOM), Director provides strategic and operational leadership for the country LSOM organization and is accountable for the quality, timeliness, cost, and compliant execution of the country clinical study portfolio. The role translates global clinical development strategy into country operating priorities and achieves results through LSOM Senior Managers and their FTE and FSP teams. The position directs portfolio delivery, resource and capacity strategy, financial planning, quality and risk management, vendor performance, and inspection readiness from feasibility through study close-out. As a member of the country leadership team, the Director influences study placement and portfolio decisions, leads resolution of significant operational issues, develops organizational capability and succession plans, and represents LSOM operations in country, regional, and global governance forums. The Director leads and develops LSOM leaders and teams, builds partnerships with CRA and other cross-functional organizations, and promotes an inclusive, accountable culture focused on operational excellence and continuous improvement. The role also oversees resource allocation and FSP supplier performance, ensures regulatory and quality compliance, and supports inspections and the adoption of improved operating models and technologies.
Requirements
- Doctorate degree and 4 years of clinical research experience, or a Master’s degree and 7 years of clinical research experience, or a Bachelor’s degree and 9 years of clinical research experience.
- Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight.
- Strong project management experience.
- Experience managing multiple teams or direct reports across multiple clinical functions or trials.
- Experience at, or oversight of, clinical research vendors such as CROs, central labs, or imaging vendors.
- Experience managing clinical operations across the relevant geography or region, including understanding of local regulatory requirements for global clinical trials.
Nice To Haves
- Four years of direct managerial and/or leadership experience, or equivalent.
- Ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization.
Responsibilities
- Lead the successful delivery of the country study portfolio through the LSOM management organization, aligned with global clinical development priorities.
- Provide strategic direction for the country LSOM organization throughout feasibility, study execution, and study close-out.
- Oversee portfolio delivery, quality, risk, timelines, and performance, escalating and resolving critical issues in a timely manner.
- Manage LSOM and vendor performance and serve as a primary escalation point for local study challenges.
- Coach and develop LSOM Senior Managers, including performance management, succession planning, and leadership bench development.
- Build organizational capabilities and plan resourcing to meet current and future portfolio requirements.
- Partner with the CRA organization on study start-up, monitoring, issue resolution, and compliant trial execution.
- Promote a high-performing, inclusive, accountable, patient-focused culture and continuous improvement across distributed teams.
- Integrate study strategy with local execution and strengthen cross-functional alignment and accountability across country teams.
- Provide strategic input into study placement and portfolio investment decisions based on country capabilities, readiness, performance, and growth potential.
- Anticipate portfolio delivery risks, quality trends, and resource needs; direct mitigation strategies and systemic improvements.
- Sponsor initiatives that advance operational efficiency, digital innovation, organizational capability, and adoption of leading practices.
- Direct resource strategy, capacity planning, workload allocation, and FSP/FTE team resourcing in alignment with global priorities.
- Ensure compliance with applicable regulatory, GCP, ICH, and organizational standards across the country study portfolio.
- Partner with Regional Head/Country Head and senior cross-functional stakeholders to align priorities, establish accountability, and resolve escalations.
- Coordinate country functional teams and collaborate with CRAs, CSPO, Quality, and FSP partners to deliver the country portfolio.
- Ensure inspection readiness and provide hands-on inspection support, including responsibility for storyboards.
- Lead organizational changes and enable adoption of new operating models and technologies.
- Set delivery goals, operating expectations, and performance standards across study start-up, site engagement, monitoring, execution, and closeout.
- Manage LSOM resources in accordance with global study strategy; oversee workload balance and FSP supplier resource coordination and performance.
- Monitor FSP performance through quality oversight metrics, identify and report related risks or compliance concerns, and escalate issues to the Regional/Country Head as needed.
Benefits
- Retirement and Savings Plan with company contributions
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Time-off plans
- Flexible work models where possible
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
