Do you have a minimum of 3 years experience as a CRA, and are you looking forward to a coordinating position in clinical research? You are fluently trilingual, a good communicator able to interact with different people? You are a bridge-builder, with a pro-active and problem-solving attitude? Then this is a great opportunity!
Job Description
The Feasibility & Site Engagement Manager is responsible for the management of clinical sites being considered and/or participating in Client clinical trials; inclusive of site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery.
Responsibilities
- Accountable for activities required at clinical trial sites and by investigators and site staff participating in Client trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out
- Accountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolution
- Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience
- Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data
- Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable
- Responsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and database locks
- Ensure site and country level inspection readiness at all times
- Leverage metrics to inform site/country/regional level decision making
- Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required
- Establishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in Client clinical trials.
- Perform targeted sites prospecting in alignment with portfolio strategy & priority
- Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel
- Serve as an effective communication "bridge" between sites, third party vendors and Client
Requirements
- Bachelor's degree or equivalent in a scientific or health-related field
- Minimum of 3 years' experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice
- Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs
- Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
- Demonstrated strategic agility & broad business acumen
- Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty
- Strong communication (both verbal and written) and language skills (NL, FR and EN)
- Strong organizational/planning skills
- Strong knowledge in country regulatory guidelines/requirements
- Strong teamwork and interpersonal skills
- Demonstrated decision-making ability
- Travel required (50-75%)
Benefits
- A balanced salary package based on your capabilities and experience.
- Full Time position
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17755
