Regional Clinical Operations & Feasibility Manager
The Position
Provides strategic leadership, functional expertise, and operational oversight for clinical trial business operations and feasibility management at the country/regional level. Ensures efficient planning, execution, and monitoring of clinical programs, maximizes business opportunities, and drives operational excellence through stakeholder engagement, resource management, and continuous improvement.
Tasks and responsibilities
Strategic Operations & Feasibility Leadership
- Drive, consolidate, and communicate strategic insights from country/regional teams to optimize clinical development and business opportunities.
- Lead country and regional feasibility assessments, ensuring alignment with strategic objectives and operational excellence.
- Build and maintain relationships with external experts, Centers of Excellence, Patient Organizations, and key partners to support feasibility and trial delivery.
- Utilize digital tools, patient registries, and predictive analytics to support feasibility and recruitment activities.
- Coordinate workforce capacities, resource planning, and performance oversight for clinical trial teams.
- Support contract negotiation and management with CROs, suppliers, and sites, ensuring harmonized strategies and compliance.
- Oversee trial budgets, purchase orders, invoicing, and payment processes to ensure timely and accurate financial management.
Stakeholder Engagement & Collaboration
- Develop and maintain strong working relationships with cross-functional partners in CDO, Medicine, Brand teams, Regulatory Affairs, Market Access, Finance, Legal, and other departments.
- Engage with external stakeholders, including investigators, site staff, Patient Organizations, Research Networks, Government bodies, Industry Associations, CROs, and service providers.
- Represent the organization in internal and external meetings, working groups, and industry forums.
- Communicate effectively with internal and external partners to facilitate trial delivery, feasibility assessments, and strategic initiatives.
Process Optimization & Continuous Improvement
- Support the development, implementation, and maintenance of business support tools for capacity planning, resource allocation, and strategic insight consolidation.
- Foster a performance-driven culture, continuous improvement, and best practices implementation across country/regional teams.
- Identify gaps in expertise, relationships, and processes; create and execute strategic plans to close gaps and optimize trial delivery.
- Capture, report, and share meaningful insights (treatment landscapes, patient pathways, guidelines, expert feedback) to inform trial design and execution.
- Support optimal site selection, trial startup, and patient/site engagement strategies.
Regulatory & Compliance
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- Adhere to national and international regulatory, legal, scientific, and ethical standards, including ICH GCP, local regulations, and BI SOPs.
- Ensure all interactions and engagements are carried out with the highest ethical and professional standards and a focus on speed, quality, and patient value.
Requirements
Required
- Minimum B.S. degree; advanced degree (Masters, PhD, MD) preferred.
- At least 5 years' clinical research experience.
- Professional experience in pharmaceutical industry or CRO.
- Previous experience leading teams.
- Comprehensive knowledge of clinical research and operational processes.
- Srtategic vision and business acumen.
- Solid experience working with crossfunctional teams.
- Understanding of local/regional regulations, compliance frameworks, and standard of care.
- Experience working with CROs and external experts.
- High competency in technology and digital tools.
- Advanced in english
Desirable
- Experience in similar positions will be considered an added value.
- Regional scope experience.