Clinical Operations leads the global execution of Phase IβIV clinical trials across therapeutic areas, ensuring studies are conducted in compliance with SOPs, company policies, and regulatory requirements while delivering timely, high-quality data to support registration and commercialization.
The Senior Clinical Trials Manager leads studies within a program, provides direction to Clinical Operations team members, and is accountable for execution against timelines, budgets, and quality standards. This role develops study operational strategies and may contribute to cross-functional or organizational initiatives.
Responsibilities:
- Lead all aspects of assigned clinical studies within a program, including Study Management Team leadership as applicable.
- Develop, implement, and oversee study plans, timelines, logistics, budgets, and resourcing.
- Ensure studies are delivered on time, within budget, and aligned with quality, protocol, SOP, and regulatory requirements.
- Identify study risks and drive mitigation and issue-resolution strategies.
- Lead CRO/vendor selection, oversight, deliverable management, and relationship management as applicable.
- Partner with cross-functional stakeholders on objectives, priorities, timelines, and deliverables.
- Provide guidance/training to internal teams, CROs, vendors, and investigators.
- Mentor less experienced colleagues.
- Contribute to process improvement, standardization, operational excellence, and departmental initiatives.
Basic Qualifications:
- BA/BS with 6+ years relevant clinical or related life sciences experience; or MA/MS with 4+ years.
- Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements.
Preferred Qualifications:
- Advanced degree (MA/MS, PharmD, or PhD).
- Experience leading clinical studies and cross-functional project teams.
- Ability to lead teams, coach, and mentor.
- Strong communication/interpersonal skills; success in matrixed environments.
- Full-cycle study management (start-up through close-out).
- Advanced knowledge of study management best practices/tools.
- Ability to travel as needed.
Application instructions (if applicable): Please apply via the Internal Career Opportunities portal in Workday.