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 quality, timeliness, cost, and compliant execution of the country clinical study portfolio. The role works through LSOM Senior Managers and their FTE and FSP teams to translate global clinical development strategy into country operating priorities. The Director leads 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 role influences study placement and portfolio decisions, resolves significant operational issues, develops organizational capability and succession plans, and represents LSOM operations in country, regional, and global governance forums. The role provides line management and leadership for LSOM Senior Managers and teams, establishes delivery goals and performance expectations, supports cross-functional alignment, and fosters an inclusive, accountable, patient-focused culture. It also ensures compliance with applicable regulatory, GCP, ICH, and organizational standards throughout the country's study portfolio.
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.
- Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization.
- Strong project management experience.
- Experience managing multiple teams or direct reports across multiple clinical functions or trials.
- Experience managing clinical operations across the relevant geography or region, including understanding local regulatory requirements for global clinical trials.
Nice To Haves
- Four years of direct managerial and/or leadership experience, or equivalent.
- Experience at or oversight of clinical research vendors, such as CROs, central labs, or imaging vendors.
Responsibilities
- Lead delivery of the country study portfolio through the LSOM management organization, aligned with global clinical development priorities.
- Provide strategic direction to the country LSOM organization across feasibility, study execution, and study close-out.
- Oversee portfolio delivery, quality, risk, timelines, and performance, and direct escalation and resolution of critical issues.
- Manage LSOM and vendor performance, serve as the primary escalation point for local study challenges, and drive solutions to meet portfolio targets.
- Coach and develop LSOM Senior Managers and the broader organization, including performance management, succession planning, and leadership bench development.
- Build organizational capabilities and resource plans to meet current and future portfolio requirements.
- Partner with the CRA organization to support study start-up, monitoring, issue resolution, and compliant trial execution.
- Coordinate country functional teams to ensure successful delivery of the country portfolio.
- Strengthen cross-functional alignment and accountability across country teams and integrate study strategy with local execution.
- Influence study-placement and portfolio investment decisions using insight into country capabilities, readiness, performance, and growth potential.
- Anticipate delivery risks, quality trends, and resource needs, and direct mitigation strategies and systemic improvements.
- Sponsor operational efficiency, digital innovation, continuous improvement, and adoption of leading practices and new operating models or technologies.
- Direct resource strategy, capacity planning, workload allocation, and FSP/FTE team coordination in alignment with global priorities.
- Oversee FSP supplier resource coordination and performance using quality oversight metrics, and identify and report FSP-related risks or compliance concerns.
- Ensure inspection readiness and provide hands-on inspection support, including responsibility for storyboards.
- Ensure compliance with applicable regulatory, GCP, ICH, and organizational quality standards.
- Collaborate with the Regional Head/Country Head and senior cross-functional stakeholders to align trial deliverables, priorities, and accountability, and resolve significant escalations.
- Represent LSOM operations in country, regional, and global governance forums.
- Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams.
Benefits
- Health and welfare plans for staff and eligible dependents
- Retirement and savings plan with generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Award-winning 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
