Key Trial Capabilities Associate
We are seeking a highly motivated and organized Key Trial Capabilities Associate to join our team. The successful candidate will be responsible for ensuring investigator sites meet requirements to enroll study participants into clinical trials and supporting ongoing activities during site maintenance and closeout.
The ideal candidate will have a strong understanding of project management processes and skills, as well as effective communication, negotiation, and problem-solving skills. Additionally, they will possess self-management and organizational skills, with the ability to work independently and as part of a team.
Responsibilities:
* Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA) (where applicable), supervise and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
* Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
* Identify, communicate, and resolve issues
* Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
* Leverage previous site / review board engagements to efficiently drive new work
* Promote trial prioritization and anticipate and monitor dynamically changing priorities
In this role, you will have the opportunity to work on a variety of projects and contribute to the development of clinical trials. If you are a detail-oriented and organized individual with excellent communication skills, we encourage you to apply for this exciting opportunity.
Qualifications:
* Bachelor's degree preferably in a scientific or health-related field
* Two years of clinical research experience or relevant experience preferred
* Strong understanding of the overall clinical development paradigm and the importance of efficient site initiation
* Applied knowledge of project management processes and skills
* Effective communication, negotiation, and problem-solving skills
* Self-management and organizational skills
* Language capabilities in English and French are essential (Flemish speaking a plus)
We offer a comprehensive benefits package that includes flexible hybrid working options, healthcare, pension, and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking. Our organization is committed to diversity, equity, and inclusion, and we strive to create an environment where all colleagues feel valued, respected, and empowered to succeed.