Summary
The country Associate Director Clinical Operations responsibilities include leadership and local strategic planning and operational delivery of assigned clinical trials to support Incyte’s pipeline, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, Incyte SOPs, local operating guidelines and local requirements, as applicable. The Country Clinical Operations Manager works locally toward Global Development Operational targets for recruitment and completion of R&D clinical trials within expected timelines. In addition, the position requires management of local CRAs and local oversight of vendors.
Responsibilities
- Has accountability and oversight for all assigned studies at country level in accordance with the overall plan and under the direction of the global team (Global Clinical Trial Manager) including adherence to quality and timelines.
- Executes country clinical trials goals and commitment, and ensures compliance to relevant processes
- Collaborates cross functionally within country to build strong interaction (e.g. Medical Affairs, Medical Science Liaisons, medical team, etc…).
- Provides to Global study team with feedback from a country perspective
- For in-house studies, works with the Study Start-up team, ensures timely submission of all ethical and administrative submissions and helps to ensure their appropriate approval.
- Oversees country sites feasibility and selection, site monitoring performance and all relevant activities for clinical operations
- Collaborates with the Global Study Team, to develop and execute, when necessary, local contingency plans and risk management plans, identifying critical issues for the country
- Collaborates in country quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and oversee implementation of Corrective Action Plan as appropriate
- Provides direct line management to CRAs by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow-up to ensure team performance is fully optimized
- Develops, builds and maintains optimal relationships with key institutions within the country, working closely with Medical Affairs/other country departments regarding site engagement strategy.
- Ensures that clinical trials data from sites are delivered in accordance with established dataflow, timelines and quality.
- Ensures that internal Clinical Trial Management System tracking tools and other systems are populated and maintained up-to-date for the country.
- Leads and/or organizes and/or participates in country or regional meetings
- Communicates regularly on country clinical operations status and escalates unresolved issues appropriately to the country Medical Director and/or ED, Clinical Operations and/or Global Study Team
- Proactively incorporates learning and recommendation from clinical trials debriefs and best practices.
- Manages issues related to local invoices and provide oversight of any budget reconciliation when needed, in collaboration with Finance department.
- Maintains oversight and ensures consistency across clinical trials in the country.
- Contributes to improve global, regional and country processes
Requirements
- Minimum Bachelor’s degree with at least 5-7 years of experience in Clinical Trial operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management. Local experience is a plus.
- Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred oncology experience.
- Good knowledge and experience of working with external specialist vendors
- Direct management experience and supervisory responsibility. Demonstrated leadership and management skills.
- Excellent written/verbal communication skills
- Excellent interpersonal, organizational, and problem-solving skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel.
- Proficient in Outlook/Word/Excel/PowerPoint.
- Must be able to travel (domestic and international) up to 25%
- Goal oriented, self-starter with proven ability to work independently;
- Able to proactively identify issues and provide solutions for resolution;
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and quality;
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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