Study Start-Up Lead (SSUL)
Brussels-Capital
Life Sciences - Clinical
Master, Phd
Work experience: 5-7
Reference number: 91384
Regulatory & Ethics Submissions
- Lead the preparation, coordination, and submission of clinical trial applications to Ethics Committees and the national competent authority (AFMPS/FAMHP).
- Oversee submission of amendments and ensure compliance with local regulations and ICH-GCP guidelines.
- Maintain accurate documentation and track submission progress.
Study Start-Up Management
- Manage the full study start-up lifecycle, including feasibility input, submission planning, approval tracking, and site activation.
- Develop country-specific Informed Consent Forms (ICFs) in French and Dutch, ensuring alignment with regulatory requirements.
- Coordinate with internal teams to ensure timely site readiness and activation.
Process Optimization & Innovation
- Identify opportunities to optimize, automate, or standardize start-up processes at both country and site level.
- Contribute to the implementation of harmonized processes across regions and global teams.
Cross-Functional Collaboration
- Collaborate closely with global study teams, country operations, regulatory affairs, site management, and vendors.
- Ensure strong communication and alignment between local and international stakeholders throughout the start-up phase.
Budget & Contract Support
- When required, support budget and contract negotiations with clinical sites and internal business partners.
- Ensure documentation and approvals follow internal procedures.
What are we looking for?
Education
- Bachelor’s or Master’s degree in Life Sciences (e.g., biomedical sciences, pharmacy, biology) or equivalent experience in clinical research.
Experience
- Minimum 2–5 years of experience in clinical research, ideally in study start-up, regulatory submissions, or site activation.
- Experience with Ethics Committees, regulatory submissions, and ICF development in Belgium is highly valued.
Technical Skills
- Strong knowledge of ICH-GCP and Belgian regulatory requirements.
- Experience with clinical systems such as eTMF, CTMS, or Veeva.
- Solid project management and documentation skills.
Languages
- Fluent in French, Dutch, and English (written and spoken).
Competencies
- Strong organizational and prioritization skills.
- Ability to manage multiple studies simultaneously.
- Excellent communication and stakeholder management.
- Detail-oriented, rigorous, and proactive.
- Problem-solving mindset and ability to work independently.
- Comfortable in cross-functional and multicultural environments.
What do we offer?
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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