Clinical Project Manager

SolCur; Belgique; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Telework

Flexible hours

32 days holiday

Company car

Résumé du poste

SolCur is seeking a Clinical Trial Manager to oversee all clinical operational aspects of global studies from planning through closure. You will coordinate stakeholders, manage risk and budgets, and ensure quality and regulatory compliance across trials.

The role requires strong ICH-GCP knowledge and 5+ years in Clinical Operations, with experience managing CROs and vendors. Telework is possible within a hybrid work model.

Qualifications

• Strong knowledge of ICH-GCP and regulatory guidelines.
• Experience in clinical operations managing CROs and vendors.
• Minimum 5 years of experience in Clinical Operations.

Responsabilités

• Oversee all clinical operational aspects of global studies from planning to closure.
• Coordinate internal and external stakeholders and lead trial team meetings as needed.
• Manage risk, timelines, budget, and quality in collaboration with the Clinical Operations Lead.
• Ensure trials comply with CDP, study plans, procedures, and regulatory requirements (ICH-GCP).
• Lead CRO/vendor selection and oversee performance with key metrics.

Connaissances

ICH-GCP knowledge

Stakeholder management

Project management

Formation

Bachelor’s or Master’s degree in life sciences or related field

Outils

MS Project

Clinical tracking systems

EDC platforms

Description du poste

The Clinical Trial Manager is responsible for overseeing all clinical operational aspects of assigned global clinical studies from planning through to study closure. This includes coordination of internal and external stakeholders, ensuring quality standards, and adherence to timelines and budget.

Main activities are:

• Actively participates in clinical trial team meetings; when serving as Lead CTM, co-leads these meetings alongside the lead trial physician.
• Manages risk identification and mitigation for clinical trials, proactively offering solutions and ensuring implementation.
• Oversees all trial-related activities including budget, timelines, and quality; collaborates closely with the Clinical Operations Lead on issue resolution and project adjustments.
• Ensures clinical trials are conducted in alignment with the Clinical Development Plan (CDP), project objectives, study plans, and in compliance with internal procedures, ICH-GCP, and applicable regulations.
• Supports the selection of contract research organizations (CROs) and vendors; plays a lead role in contract negotiations alongside internal vendor management.
• Leads and monitors the performance of external partners (e.g., CROs, laboratories) based on key metrics and timelines.
• Acts as a member of the country and site selection committee for the assigned study.
• Contributes to or develops essential study documents including protocols, monitoring plans, data management plans, eCRFs, patient information forms, informed consent forms, and recruitment materials.
• Tracks patient enrollment, implements strategies to avoid recruitment delays, and optimizes retention initiatives.
• Develops site monitoring and oversight strategies; ensures compliance through visits and regular assessments.
• Reviews monitoring visit reports, protocol deviations, and data trends to proactively detect and resolve issues while maintaining high data quality.
• Ensures proper management and up-to-date status of the Trial Master File (TMF).
• Coordinates investigational product (IP) supply and ensures site accountability documentation is in place and maintained.
• Oversees adverse event (AE) and serious adverse event (SAE) reporting processes and supports regulatory submissions as required.
• Fosters strong relationships with investigative sites and site personnel, ensuring clear expectations and motivation across the trial team, including vendors.
• Leads issue resolution processes and escalates concerns to senior clinical operations leadership when needed.
• Serves as a key contact during audits or inspections for the assigned clinical trial, in partnership with Quality Assurance representatives.
• Promotes process improvements, shares best practices and innovations across teams and trials.

Qualifications

• Strong knowledge of ICH-GCP and relevant clinical research regulations.
• Proficient with clinical study management tools (e.g., MS Project, clinical tracking systems, EDC platforms).
• Bachelor’s or Master’s degree in a medical or life sciences discipline (e.g., Biology, Biomedical Sciences, Pharmacy, Veterinary Medicine) or equivalent through experience.
• At least 5 years of experience in Clinical Operations, with demonstrated ability to manage CROs and vendors.
• Experience in biotech settings is a plus.
• Background in autoimmune or oncology trials is considered advantageous.

What we offer:

• We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
• We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review)
• Side activities will be organised regularly, to achieve a close collaboration within our team
• We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
• We contribute to a number of charities & support the research and / or the patients in our industry.