Clinical Trial Manager

Solutia Life Sciences (recruitment division of Solutia) specializes in technical and middle management profiles in the pharmaceutical, biotech, and medical device sectors.

We are currently looking for a Clinical Trial Manager for an important company in the pharmaceutical sector, located in Barcelona.

Purpose of the job :

Plan, budget, coordinate and execute allocated clinical trials and assist with training and development of clinical monitoring tasks. Primary contact with CRO PM.

Major accountabilities

• Oversee all clinical trial activities by project.
• Develop and track a project plan (with timelines and objectives), under the coordination of the Director of Clinical Operations. Contribute to trial-specific document development. Contribute to site and CRO selection. Assist project team with site initiation visits. Ensure that data documentation and insurance requirements are met. Control the full execution of site contracts.
• Manage project deliverables, improve patient recruitment, ensure compliance with regulatory requirements, and meet objectives within approved budgets and timelines. Report to the Clinical Development Director regarding quality, milestones, timelines, and budgets.
• Provide leadership to ensure the integrity of clinical data regarding accuracy, accountability, documentation, and procedures through review of case report forms. Recognize, detect, and prevent fraud and misconduct. Implement corrective actions when necessary.
• Assist the Director of Clinical Operations in planning and organizing all key project milestones (e.g., Investigators meeting, Safety Plan, BDRM, SAP, etc.).
• Develop and track a project budget under the supervision of the Clinical Operations Director: predict costs, develop time-phased budgets, and manage internal and external partners, including contract management, negotiation, and payment tracking (clinical research sites, CRO, outside consultants).
• Lead the in-house study team when applicable. Coordinate and steer activities of all team members, including CTO and CTAs.
• Lead CRAs, CTCs, and CTAs within a project team (in-house or outsourced). Validate the skills of outsourced clinical trial team members. Conduct study-specific training. Serve as in-house and on-site coach for CRAs. Coordinate and steer all team activities, including site visits if not covered externally.
• Manage as the primary contact the CRO PM. Validate skills of outsourced trial team members, conduct training, and serve as on-site coach for CRAs.
• Co-chair project team meetings with CRO and review minutes. Review monitoring visit reports both in-house and outsourced.

Assist in the review of audits and preparation of CAPA plans.

• Lead IMP needs assessment and supervise CTO or designee, IMP shipment activities. Contact logistics vendors as needed.
• Assist in developing departmental SOPs, WI, and study-specific procedures. Ensure compliance with SOPs, policies, ICH GCP, and applicable regulations.
• Coordinate logistics activities to ensure IMP availability, liaise with vendors, evaluate budgets, and supervise IMP shipment activities in ongoing trials.

Requirements :

• University degree in a scientific, medical, or paramedical field.
• Minimum five (senior) to ten years of experience in clinical research (Pharma or CRO).
• Experience in clinical development from Phase I to III.
• Excellent knowledge of clinical drug development processes.
• Knowledge of global clinical trial regulations and guidelines (GCP, GPV, EMEA, FDA, ICH, local laws).
• Effective communication skills in English and Spanish.
• Ability to collaborate effectively with project leaders, study team members, cross-functional teams, and external partners.
• Proficiency in email, Word, Excel, with development of project management software skills.