Under the guidance of the EU Study Start-Up Manager of Clinical Trial Logistics, this position will be responsible for conducting end-to-end site start-up from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities.
Duties and Responsibilities
- Serve as the primary point of contact to study team on an end-to-end start-up activity
- Participate in or lead Study-Start-up team meetings as appropriate
- Utilize Study Start-Up tools to track activities and develop reports
- Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires
- Conduct site contract/budget negotiations (Confidentiality Agreement and Clinical Trial Agreements)
- Collect essential documents from sites, tracking & review led by Document Management Team
- Support the collection of country and site level intelligence
- Complete, manage and/or support Ethics Committee and Regulatory Authority submissions
- Where required, complete, manage and/or support the country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate.
- At least 5 years of experience in site start-up and contract management in a pharmaceutical company or in a clinical research organization.
- BA/BS degree in Science or related field.
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
- Strong presentation, documentation, and interpersonal skills.
- Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and the Internet.
- Ability to handle multiple tasks to meet deadlines, delivering high-quality work in a dynamic environment.
- Excellent oral and written communication skills.
- Proficient in Dutch, French, and English
- Excellent planning and organizational skills with effective time management.
- Excellent interpersonal skills.
- Thorough understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- Thorough understanding of clinical research principles and processes.
- Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines, and country/local regulatory requirements (preferably in Belgium, the Netherlands, and if possible also in France).
- Goal-oriented, self-starter with proven ability to work independently;
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines;
- Comfort with ambiguity; ability to act without having the total picture.
- Ability to proactively identify and solve problems.