Study Start-Up Lead (SSUL)

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.

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.

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