Senior Manager, Clinical Trial Study Start Up
Jazz Pharmaceuticals
4 months ago
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Senior Manager, Clinical Trial Study Start-Up
Essential Functions/Responsibilities:
- Lead and manage end-to-end clinical study start-up activities for assigned trials, including country/site activation strategies, country assessment and timeline input, regulatory submissions, essential document collection, and country and site readiness.
- Establish SSU operational objectives and work plans for SSU staff or CRO partners; ensure efficient delegation and oversight of start-up deliverables.
- Identify and communicate risks to study, country, or site start-up; implement solutions aligned with broader clinical program goals.
- Oversee CRO performance for start-up activities and ensure compliance with timelines, budgets, metrics, and regulatory standards.
- Interact with cross-functional peers and leadership to influence decisions, build alignment on complex/sensitive matters, and maintain collaborative relationships.
- Provide expert input into budget planning, timelines, performance metrics, and resource recommendations for study start-up execution.
- Serve as key contact for country and site start-up progress; report regularly to CTWG and SSU leadership with status updates, KPI tracking, risk mitigation, and issue resolution.
- Lead or contribute to initiatives to improve start-up methodology, quality, tools, and process efficiency.
- Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions.
Required Knowledge, Skills, and Abilities:
- Subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways.
- Experience establishing and managing work plans, performance metrics, and budgets in in-house and outsourced models.
- Ability to analyze complex issues and use 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 operational clinical research experience, including 3+ years in study start-up operations and team leadership.
Benefits (US candidates only; explicitly stated):
- Discretionary annual cash bonus or incentive compensation (depending on role), discretionary equity grants, medical/dental/vision insurance, 401(k) retirement savings plan, and flexible paid vacation.
Application Instructions:
- If you are a current Jazz employee, apply via the Internal Career site.
Essential Functions/Responsibilities:
- Lead and manage end-to-end clinical study start-up activities for assigned trials, including country/site activation strategies, country assessment and timeline input, regulatory submissions, essential document collection, and country and site readiness.
- Establish SSU operational objectives and work plans for SSU staff or CRO partners; ensure efficient delegation and oversight of start-up deliverables.
- Identify and communicate risks to study, country, or site start-up; implement solutions aligned with broader clinical program goals.
- Oversee CRO performance for start-up activities and ensure compliance with timelines, budgets, metrics, and regulatory standards.
- Interact with cross-functional peers and leadership to influence decisions, build alignment on complex/sensitive matters, and maintain collaborative relationships.
- Provide expert input into budget planning, timelines, performance metrics, and resource recommendations for study start-up execution.
- Serve as key contact for country and site start-up progress; report regularly to CTWG and SSU leadership with status updates, KPI tracking, risk mitigation, and issue resolution.
- Lead or contribute to initiatives to improve start-up methodology, quality, tools, and process efficiency.
- Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions.
Required Knowledge, Skills, and Abilities:
- Subject matter expert in clinical site start-up with strong operational understanding of global regulatory requirements, IRB/EC processes, and site activation pathways.
- Experience establishing and managing work plans, performance metrics, and budgets in in-house and outsourced models.
- Ability to analyze complex issues and use 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 operational clinical research experience, including 3+ years in study start-up operations and team leadership.
Benefits (US candidates only; explicitly stated):
- Discretionary annual cash bonus or incentive compensation (depending on role), discretionary equity grants, medical/dental/vision insurance, 401(k) retirement savings plan, and flexible paid vacation.
Application Instructions:
- If you are a current Jazz employee, apply via the Internal Career site.