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About the role
- Senior Manager leading global site activation for clinical trials at biotechnology company. Overseeing project execution, team collaboration, and strategic oversight for high profile studies.
Responsibilities
- Develop the site start up strategy for each study assigned (complex, high profile)
- Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions
- Advocate for optimized site selection strategies
- Lead the development, assessment, and alignment of site activation projections
- Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF)
- Partner with cross-functional and CRO partners to develop a comprehensive global country start up strategy
- Monitor and maintain country intelligence data to support informed decision-making
- Support regulatory submissions as needed
- Ensure timely country submission deliverables
- Lead and oversee all aspects of site start-up activities for complex, high profile studies
- Serve as the subject matter expert for essential site documents
- Lead the collection and analysis of site intelligence to support strategic site selection and site start-up
- Oversee the preparation and approval of site regulatory packages
Requirements
- Bachelor's degree
- 8+ years of relevant industry experience
- Strong interpersonal and leadership skills
- Ability to provide and implement operational strategic direction and guidance for respective clinical trials
- Strong knowledge and a data-driven approach to planning, executing, and problem solving
- Strong communication skills via verbal, written and presentation abilities
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Ability to influence and negotiate across a wide range of stakeholders
- Ability to lead and develop productive study teams and collaborations
- Applies advanced negotiation and interpersonal skills to vendor management
- Strong technical proficiency in trial management systems (CTMS, TMF) and MS applications (Project, PowerPoint, Word, Excel)
- Extensive experience in the clinical drug development process, including study start-up
- Knowledge and understanding of ICH/GCP and regulatory guidelines/directives
- Strong project management skills, cross-functional team interaction, and organizational skills
- Line management experience preferred
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave) for eligible employees
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