[Remote] Senior Manager, Clinical Trial Study Start Up

Note: The job is a remote job and is open 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 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 reputed company 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
• reputed company 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 reputed company 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 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 resolution
• reputed company 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 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, Veeva 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 positive 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 Jazz's Long Term Equity Incentive Plan
• Medical, dental and vision insurance
• 401k retirement savings plan
• Flexible paid vacation Company Overview
• reputed company is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.

It was founded in 2003, and is headquartered in Palo Alto, California, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship

• reputed company has a track 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. Apply tot his job

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