Trial Operations Manager - Belgium, Netherlands
Description of the PositionThe Trial Operations Manager responsibilities include leadership, strategic planning and operational delivery of assigned clinical trials to support company’s pipeline in the Benelux.
Amongst others, responsibilities include
• Leads the Benelux study teams, representing the country and Clinical research Associates and provides Global team with feedback from a country perspective (Global Studies)
• Oversees study feasibility, site monitoring performance and all relevant activities for assigned studies
• Collaborate cross functionally with company’s country staff to build strong interaction at local level (i.e. Medical Science Liaisons, medical team).
• Collaborates with the Global Study Team, and when necessary, develops and executes, the local implementation of the risk management plans, identifying critical issues for the country and ensuring contingencies are established and captured in the study level risk management plan.
• Provides direct line management to Clinical Research Associates (CRAs) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow-up to ensure team performance is fully optimized
• Contributes to activities to improve and maintain quality and effectiveness of processes and activities within the function.
• Makes an active contribution to therapeutic area strategy teams ensuring knowledge sharing of local interest.
• If appropriate, review CRO monitoring plans and training plans for studies conducted in the country
Demands of the Position• The position requires a minimum Bachelor’s degree with 5-7years 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.
• Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred oncology experience.
• Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel.
• Goal oriented, self-starter with proven ability to work independently;
• Able to proactively identify issues and provide potential solutions for resolution;