Clinical Trial Coordinator – FSP, client dedicated

This is a fully remote position, open to applicants in Belgium, +1 more country.

📋 Description

• Coordinate, manage, and complete assigned clinical trial activities in accordance with the task matrix.

• Conduct reviews of departmental, internal, country, and investigator files, documenting any findings.

• Ensure that assigned tasks are completed punctually, within budget, and adhere to quality standards.

• Communicate any project risks to project leads and the line manager.

• Maintain comprehensive study documentation, team lists, training trackers, system access, and project activity plans.

• Keep the electronic Trial Master File (eTMF) current and provide support for the eTMF and GoBalto systems.

• Assist in risk-based monitoring activities.

• Process trial documents, perform eTMF reviews, manage mass mailings, and generate reports.

• Schedule and organize client and internal meetings, and prepare minutes for these meetings.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized Institutional Review Boards (IRB) or Ethics Committees (IEC).

• Analyze and reconcile study metrics and findings reports.

• Aid in clarifying and resolving issues related to site documentation findings.

• Maintain vendor trackers.

• Coordinate, compile, and distribute materials for the Investigator Site File, Pharmacy binder, and non-clinical study supplies.

• Assist with the creation of study-specific translation materials and ensure translation quality control.

• Attend kick-off meetings and take notes as necessary.

• Act as a study lead or serve as a cross-functional liaison when required.

• Mentor and train new staff members during their onboarding process.

• Contribute to departmental and cross-functional process improvement initiatives.

⛳️ Requirements

• High/Secondary school diploma or equivalent, alongside relevant formal academic or vocational qualifications.

• Prior experience that provides the knowledge, skills, and abilities necessary to perform this role, equivalent to at least 4 years.

• Equivalency can be achieved through a combination of relevant education, training, and/or directly related experience.

• Capability to work both independently and as part of a team, as needed.

• Strong organizational skills and attention to detail, with the ability to manage multiple tasks efficiently and effectively.

• Ability to analyze project-specific data and systems to ensure accuracy and efficiency.

• Strong customer service orientation.

• Flexibility and adaptability to adjust workload priorities and meet changing project timelines.

• Familiarity with relevant Country Regulations, ICH Good Clinical Practices, and organizational/Client SOPs and WPDs.

• Excellent proficiency in Dutch and English, with strong grammar skills; French is preferred.

• Good presentation skills.

• Strong computer skills, including proficiency in MS Office (Word, Excel, and PowerPoint).

• Capacity to acquire knowledge and master clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

• Self-motivated with a positive attitude and effective interpersonal skills.

• Occasional travel to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.