Clinical Project Associate Belgium

Syneos Health; Brussel; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Syneos Health Belgium seeks a Clinical Project Associate to support site management and documentation across various study phases. You will assist monitoring staff, help prepare TMF materials, and coordinate sponsor communications.

The role emphasizes regulatory compliance, data integrity, and collaboration with cross‑functional teams in a fast‑paced environment in the Brussels region. A master’s degree in biomedical sciences and multilingual skills are required.

Qualifications

• Master degree in biomedical sciences or related.
• Strong interest in clinical research.
• Good communication and interpersonal skills.
• Fluency in Dutch, English and French.
• Ability to embrace new technologies.

Responsabilités

• Perform activities in compliance with Corporate and Clinical Operations Policies, SOPs and Work Instructions.
• Assist Clinical Monitoring staff with site management activities and sponsor communications.
• Create and maintain Trial Master File (TMF) and project files, including audits.
• Prepare and maintain site manuals, reference tools and other documents.
• Maintain clinical tracking information in databases and update investigator sites’ documents.
• Coordinate site requests, mail handling and correspondence routing.
• Coordinate ordering, packaging, shipping and tracking of site supplies.

Connaissances

Communication

Interpersonal skills

Multilingual (Dutch, English, French)

Adaptability to new technologies

Formation

Master's degree in biomedical sciences or related

Description du poste

Clinical Project Associate Belgium

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Why Syneos Health

• We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself and it unites us globally.
• We are continuously building the company we all want to work for and our customers want to work with. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives, we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
• Prepares and maintains site manuals, reference tools and other documents.
• Maintains, updates, and inputs clinical tracking information into databases.
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manages shared mailbox, processes site requests and routes correspondence appropriately.
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials.
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items.
• May handle receipt, tracking and disposition of Case Report Forms and Queries.
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.

Qualifications

• Master degree in biomedical sciences or related.
• Strong interest in clinical research.
• Good communication and interpersonal skills.
• Fluency in Dutch, English and French.
• Ability to embrace new technologies.
• Ability to work from the office in the Machelen/Zaventem region on a regular basis.

Summary

Roles within Clinical Operations are responsible for ensuring safe and effective operations of clinical research studies. Responsible for safeguarding the wellbeing of research subjects in a medical capacity. Reviews study protocols, plans and executes procedures in alignment with protocols and regulatory, health, and safety standards, raising or escalating study issues. Recruits and coordinates communication with clinical trial volunteers and patients, and follows applicable regulations globally and by region. Collaborates with cross‑functional teams to develop study materials, monitor trial progress, and address any issues that arise during the study. Impact and Contribution: Individual contributors who provide organizational related support or service (administrative or clerical), as well as roles operating in support of daily business activities (e.g., technical, production, or craft levels). The majority of time is spent in the delivery of support services or activities, typically under supervision. Roles do not typically require advanced education or training. Established and experienced support individual contributor. Work consists of tasks that are typically routine, with some deviation from standard practice. Requires broad knowledge of operational systems and practices typically gained through extensive experience and/or education.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.