Sr Mgr Local Study Operations

Accountabilities

• Lead the skill development of Local Study Operations Senior Managers ensuring the effective implementation of trials within the country and alignment with global strategies.
• Oversee the delivery of the countrys study portfolioincluding scope timelines and budgetsthrough the management of LSOM Senior Managers.
• Collaborate with the Country GSSO Head to foster enhance and sustain an optimal clinical research environment that supports global R&D objectives.
• Promote alignment and continuous improvement in LSOM execution by integrating best practices digital innovations and facilitating knowledge sharing among team members.

Responsibilities

• Ensure the successful delivery of the study portfolio assigned to LSOMs.
• Oversee LSOMs fulfillment of responsibilities throughout the assigned country portfolio from feasibility through to study close-out.
• Monitor portfolio progress provide risk and quality oversight and support issue escalation and resolution for LSOMs.
• Manage LSOM and LSOM vendor performance to guarantee high-quality study execution serving as the primary escalation point for local study challenges driving solutions and ensuring portfolio targets are met within the country.
• Mentor train and support the professional development of LSOMs to prepare them for managing complex trials.
• Build and maintain a high-performing team.
• Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio.
• Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio.
• Support discussions regarding study placement decisions based on country capabilities and growth potential.
• Proactively evaluate risks quality trends and resource requirements; implement mitigation strategies and drive continuous improvement in country operations.
• Lead initiatives to enhance operational efficiency and encourage sharing of best practices.
• Manage resource allocation and workload distribution across LSOMs including both FSP and FTE personnel to optimize trial execution and align with global priorities.
• Ensure adherence to regulatory and quality standards where applicable.
• Collaborate with and support the country head in engaging cross-functional stakeholders aligning on trial deliverables and managing escalations.

Minimum Requirements

• Doctorate degree & 2 years of clinical execution experience OR

• Masters degree & 6 years of clinical execution experience OR

• Bachelors degree & 8 years of clinical execution experience OR

• Associates degree & 10 years of clinical execution experience OR

• High school diploma / GED & 12 years of clinical execution experience

• In addition to meeting at least one of the above requirements you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Requirements (based on GTM)

• 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 managing multiple teams / direct reports across multiple clinical functions / trials
• Experience at or oversight of clinical research vendors (CROs central labs imaging vendors etc.)
• Experience managing clinical operations across relevant geography / region including strong understanding of local regulatory requirements around global clinical trials

Competencies

• Skilled in developing site-specific operational plans that enhance efficiency compliance and patient safety while implementing best practices and continuous improvement methodologies
• Proficient in ensuring site preparedness and smooth execution across all study phases by supporting site initiation visits (SIVs) recruitment calls and adherence to study timelines
• Clear understanding of country-level regulations and compliance for clinical trials keeping up to date on clinical trial that may impacting managing ethics submissions study start-up processes and site inspection readiness at a country-level
• Experience with developing and training teams related to clinical trial materials (e.g. CRAs site staff and cross-functional teams) to ensure alignment with study protocols regulatory requirements and best practices
• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues communicating and/or escalating appropriately
• Demonstrates ability for end-to-end management of study deliverables budgets timelines and performance metrics (KPIs) to optimize trial execution
• Experience with overseeing study budgets and financial operations reviewing/approving site expenditures and optimizing resource allocation to ensure cost efficiencies
• Strong collaboration and communication skills to engage with cross-functional teams senior management and external stakeholders internally and externally
• Able to identify and implement opportunities for continuous improvement into the teams working practices
• Navigates diverse regulatory cultural and operational environments. Builds strong relationships across geographies and time zones
• Ability to manage mentor and develop professionals and support staff across functions while fostering collaboration across internal and external teams for trial success