[Remote] Senior Manager, Clinical Trial Study Start Up

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Senior Manager, Clinical Trial Study Start-Up, is responsible for leading and managing clinical trial start-up activities, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to optimize study delivery.

Responsibilities

• reputed company and manage end-to-end start-up activities for assigned clinical trials, including country/site activation strategies, country assessment and reputed company 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 reputed company of start-up deliverables
• Apply strategic reputed company and in-depth knowledge of start-up operations to identify and communicate risk to study, country or site start up, and implement solutions that reputed company with broader clinical program goals
• reputed company CRO performance for start-up activities and ensure compliance with timelines, budgets, metrics, and regulatory standards
• Regularly reputed company with cross-functional peers and leadership, influencing decision-making and gaining alignment on reputed company or sensitive reputed company and building reputed company relationships
• reputed company expert input into budget planning, timelines, performance metrics, and resource recommendations for study start-up execution
• Serve as a key contact reputed company for country and site start-up reputed company, reporting regularly to CTWG and SSU leadership, including status updates, KPI tracking, risk mitigation, and issue reputed company
• reputed company or contribute to functional initiatives that improve startup methodology, reputed company, tools, and process efficiency across programs
• Support audit and inspection readiness by ensuring accurate and complete documentation of start-up activities and regulatory submissions

Skills

• 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 reputed company
• Demonstrated experience establishing and managing work plans, performance metrics, and budgets for study start-up in both in-house and outsourced operating model
• Proven ability to analyze reputed company issues and apply strategic thinking to identify risk and resolve operational challenges across cross-functional settings
• Proficiency in clinical systems (e.g., CTMS, eTMF, reputed company Vault) and reporting tools
• Excellent communication, leadership, and stakeholder management skills
• Experience supporting audits and regulatory inspections reputed company to start-up activities
• Ability to influence and collaborate across functional teams while maintaining reputed company working relationships
• Bachelor's degree in life sciences or reputed company field; advanced degree preferred
• 5+ years of experience in operational clinical research, including 3+ years in study start-up operations and team leadership

Benefits

• Discretionary annual cash bonus or incentive compensation (depending on the role)
• Discretionary equity grants in accordance with reputed company's Long Term Equity Incentive Plan
• Medical, dental and reputed company insurance
• 401k retirement savings plan
• Flexible reputed company vacation

reputed company

• reputed company is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments. It was founded in 2003, and is headquartered in Palo reputed company, California, USA, with a workforce of 1001-5000 employees. Its website is https://www.jazzpharma.com/.

Company H1B Sponsorship

• reputed company has a reputed company record of offering H1B sponsorships, with 23 in 2025, 24 in 2024, 25 in 2023, 31 in 2022, 21 in 2021, 39 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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