Senior Manager, Global Site Start Up Lead
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Manager leading global clinical trial site start-up for Regeneron’s life-changing medicines. Driving study activation, regulatory compliance, CRO performance, and operational excellence.
Responsibilities:
- Develop and execute global site and country start-up strategies for complex clinical trials
- Identify risks, dependencies, and mitigation plans
- Lead site activation planning and forecasting activities to achieve study milestones and timelines
- Partner with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to drive study start-up execution
- Monitor and evaluate start-up metrics and use data and trends to improve performance and inform strategic decisions
- Oversee regulatory document collection, submissions, site initiation readiness, and milestone tracking
- Provide leadership and direction to CRO partners and internal teams for high-quality, compliant start-up delivery
- Serve as the primary escalation point for site start-up challenges
- Resolve issues proactively and drive cross-functional alignment
- Manage and develop a team of Site Start-Up professionals through coaching, performance management, mentoring, and career development initiatives
Requirements:
- Bachelor's degree and 8+ years of pharmaceutical, biotechnology, or clinical research industry experience
- Extensive experience leading global clinical trial start-up activities, including country and site activation strategies
- Strong knowledge of ICH-GCP guidelines, clinical trial regulations, and global study start-up processes
- Demonstrated ability to lead cross-functional teams and influence stakeholders across a global organization
- Proven experience managing vendors and CROs, including performance oversight and issue resolution
- Excellent project management, communication, negotiation, and risk management skills
- Previous direct line management experience with responsibility for staff development and performance management preferred
- Experience supporting complex, high-profile, and global clinical development programs preferred
- Strong analytical mindset with a data-driven approach to forecasting, metrics review, and operational decision-making preferred
- Experience driving process improvements and operational excellence initiatives within Clinical Development preferred
- Advanced understanding of country-specific regulatory and site activation requirements across multiple regions preferred
- Ability to work primarily in a computer-based environment
- Ability to travel domestically and internationally up to 25% as required
- Ability to participate in meetings across multiple global time zones
Benefits:
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation for applicants with known disabilities or chronic illnesses
- Remote work model
- Travel up to 25%
Similar Jobs
Manager, GMP Audits
GMP audit manager at Pfizer, a biopharmaceutical company, leading global manufacturing and distribution audits. Ensuring compliance with GMP/GDP regulations, quality standards, and vendor requirements.
Senior Digital Paid Ad Manager
Senior Paid Ads Manager leading multi-channel campaigns for Horizon3’s autonomous cybersecurity platform. Driving account engagement, pipeline attribution, optimization, and revenue impact.
Technical Learning Manager
Manager leading Johnson Controls’ HVAC technical learning portfolio for customers and channel partners. Developing technical learning teams, programs, and scalable training operations.
Drug Discovery Resource Outsourcing Manager
Drug discovery outsourcing manager coordinating early R&D requests and China CRO partnerships for Absci, a generative-AI biotechnology company developing novel therapeutics.
Study Delivery Senior Manager – Study Delivery Lead
Leading end-to-end global clinical trial delivery for Amgen, a biotechnology company developing innovative medicines. Managing study teams, vendors, risks, timelines, budgets, and data quality.
Customer Business Manager II – Food City
Customer Business Manager growing CPG brands through Food City retail sales, merchandising, and strategic client plans. Supporting CROSSMARK’s data-driven retail marketing and brand activation services.
Senior Credit Manager
Senior Credit Manager owning credit policy, unit economics, and experiments for Tilt’s Mexico cash-advance product. Improving access to fair credit through mobile-first lending and machine learning.
Nurse Care Manager – Katie Beckett
Nurse Care Manager coordinating complex pediatric care, assessments, and Medicaid services for Tennessee’s Katie Beckett program. Conducting home visits and supporting families across designated Middle-South Tennessee counties.
Network Manager II
Network Manager strengthening Tennessee provider networks for BlueCross BlueShield of Tennessee. Managing provider relations, contracting, reimbursement analysis, compliance, and network performance.
Associate Manager
Associate Manager leading Manulife’s CAF LTD disability claims team supporting medically released Canadian Armed Forces veterans. Managing case operations, complex claims guidance, staff development, and service outcomes.
Strategic Accounts Manager – Data Centers
Strategic Accounts Manager driving strategic data-center automation sales for ABB Robotics. Developing account strategies, pipelines, and multi-location customer programs across the UK and Sweden.
Manager, FSA
Manager leading feasibility and site activation teams for ICON, a global healthcare intelligence and clinical research organisation. Coordinating start-up delivery, regulatory submissions, forecasts, and team development.
Senior Manager, Programs – Global Expansion, New Initiatives
Senior operations leader scaling Affirm’s global customer servicing model across products, markets, and channels. Leading cross-functional programs and teams for the financial services company.
Senior Manager, Programs – Global Expansion and New Initiatives
Senior manager shaping Affirm’s global servicing strategy for expansion programs. Leading teams and cross-functional operations across products, partners, geographies, and channels.
Area Manager
Area Manager selling Zoetis’ animal health, genomic, and veterinary products across the NSW Riverina. Building livestock-industry relationships, sales growth, and customer education.
RFID Program Deployment Manager
RFID deployment manager engineering store execution, tagging, training, and enterprise rollouts. Supporting Avery Dennison’s global materials science and digital identification solutions business.
Service Delivery Manager
Junior Service Delivery Manager supporting NSC Global’s network implementation and IT communications operations. Tracking SLAs, service requests, reporting, incidents, assets, and account coordination.
Strategic Channel Manager
Strategic Channel Manager developing Grafana Cloud’s India partner ecosystem. Driving SaaS partner strategy, co-selling, pipeline, and revenue growth through regional integrators and resellers.
Regional Field Service Manager
Regional Field Service Manager overseeing dental equipment installation, repair, and technician performance. Supporting Benco Dental, a U.S. dental distributor serving customers across 48 contiguous states.
Regional Field Service Manager
Regional Field Service Manager overseeing dental equipment installation, repair, and technicians. Supporting Benco Dental, the largest privately owned full-service dental distributor in the United States.