Senior Manager, Clinical Trial Study Start Up in London

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

The Senior Manager, Clinical Trial Study Start-Up is a subject matter expert in clinical study start-up and is responsible for leading processes that enable planning, coordination, and execution of study, country and site-level start-up activities from site identification through to site activation. This role combines operational leadership with strong cross-functional collaboration, CRO oversight, and compliance with global regulatory and quality standards.

Essential Functions/Responsibilities:

• Lead and manage end-to-end start-up activities for assigned clinical trials, including country/site activation strategies, country assessment and timeline input, regulatory submissions, essential document collection, and country and site readiness.
• Establish operational objectives and work plans for assigned SSU staff or CRO partners, ensuring efficient delegation and oversight of start-up deliverables.
• Apply strategic insight and in-depth knowledge of start-up operations to identify and communicate risk to study, country or site start up, and implement solutions that align with broader clinical program goals.
• Oversee CRO performance for start-up activities and ensure compliance with timelines, budgets, metrics, and regulatory standards.
• Regularly interact with cross-functional peers and leadership, influencing decision-making and gaining alignment on complex or sensitive matters and building collaborative relationships.
• Provide expert input into budget planning, timelines, performance metrics, and resource recommendations for study start-up execution.
• Serve as a key contact point for country and site start-up progress, reporting regularly to CTWG and SSU leadership, including status updates, KPI tracking, risk mitigation, and issue resolution.
• Lead or contribute to functional initiatives that improve startup methodology, quality, tools, and process efficiency across programs.
• Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions.

Required Knowledge, Skills, and Abilities:

• Recognized as a subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways.
• Demonstrated experience establishing and managing work plans, performance metrics, and budgets for study start-up in both in-house and outsourced operating models.
• Proven ability to analyze complex issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings.
• Proficiency in clinical systems (e.g., CTMS, eTMF, Veeva Vault) and reporting tools.
• Excellent communication, leadership, and stakeholder management skills.
• Experience supporting audits and regulatory inspections related to start-up activities.
• Ability to influence and collaborate across functional teams while maintaining positive working relationships.

Required/Preferred Education and Licenses:

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 5+ years of experience in operational clinical research, including 3+ years in study start-up operations and team leadership.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.