For one of our clients located in Brussels, we are looking for a Clinical Contracts & Regulatory Associate. This position is open to candidates with relevant experience in clinical trials within industry settings who are available full-time for an office-based role.
Job Description
The Clinical Contracts & Regulatory Associate is responsible for supporting both clinical contract management and regulatory submission activities for clinical studies. This role ensures that study agreements, budgets, and regulatory submissions are prepared, reviewed, and executed in compliance with applicable regulations, company policies, and clinical protocol requirements. The position serves as a key interface between project teams, clinical sites, and regulatory authorities, contributing to efficient study start-up and ongoing operational compliance.
Responsibilities
- Prepare, review, and edit clinical trial agreements, contracts, master agreements, work orders, and amendments.
- Support negotiation with clinical sites regarding contracts, budgets, and amendments, ensuring alignment with study requirements and regulations.
- Serve as a point of contact for clinical sites and project teams on contractual matters; escalate issues and provide recommendations to management.
- Support regulatory submissions, including preparation of documents for ethics committees (EC) and competent authorities (CA), and site-specific informed consent forms.
- Coordinate document translation and adaptation to ensure compliance with regulatory and EC/CA requirements.
- Maintain regulatory documents and contract records, ensuring accurate filing and data management.
- Assist with site activation activities, including document collection, timeline tracking, and communication with project teams and sites.
- Support project teams in interpreting clinical protocols for accurate documentation in submissions and contracts.
- Collaborate with internal stakeholders, including Legal, Compliance, and Clinical Quality, to ensure alignment on contractual and regulatory requirements.
- Participate in project meetings, prepare agendas and minutes, and facilitate communication of study activities.
- Monitor timelines for contract execution and regulatory submissions, highlighting potential risks and recommending mitigation strategies.
- Support quality management initiatives and ensure compliance with all applicable regulations, policies, and procedures.
Requirements
- Bachelor's or master's degree in life sciences, clinical research, regulatory affairs, or a related field, or relevant clinical experience in the pharmaceutical or medical device industry.
- Minimum relevant experience in clinical research within industry settings is required.
- Proficient in Microsoft Office (Word, Excel, PowerPoint) and familiar with electronic document and data management systems.
- Strong written and verbal communication skills in English; additional language skills are an advantage.
- Familiarity with clinical research processes, study protocols, and regulatory submissions.
- Knowledge of data protection and clinical study documentation requirements is preferred.
- Ability to work independently and collaboratively in a multidisciplinary, geographically diverse team.
- Strong organizational, prioritization, and multitasking skills with attention to detail.
- Ability to maintain confidentiality, handle sensitive information, and communicate effectively across all levels of the organization.
- Existing right to work in Europe is required
Benefits
- Full-time position.
- Office-based role in Brussels.
- A balanced salary package based on your capabilities and experience, including extra-legal benefits.
