Clinical Trial Manager

Solutia; Barcelona; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in the biotechnology sector is seeking a Clinical Trial Manager in Barcelona. The role involves planning and executing clinical trials, ensuring compliance with regulatory requirements, and leading project teams. Candidates should possess a relevant university degree and extensive experience in clinical research.

Servicios

Fixed Contract

Flexible entry hours

Formación

• 5-10 years of experience in clinical research (Pharma or CRO)
• Excellent knowledge of clinical drug development process
• Knowledge of global clinical trial regulations and guidelines

Responsabilidades

• Oversee all clinical trial activities by project
• Manage project deliverables and regulatory compliance
• Provide leadership ensuring integrity of clinical data

Conocimientos

Communication skills

Collaboration

Leadership

Educación

University degree in a scientific, medical, or paramedical field

Herramientas

Email

Microsoft Word

Microsoft Excel

Descripción del empleo

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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 a clinical-stage biotech company 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

1. Oversee all the clinical trial activities by project.
2. 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.
3. Manage project deliverables, improve patient recruitment, ensure compliance with regulatory requirements, and meet objectives within approved budget and timelines. Report to the Clinical Development Director regarding quality, milestones, timelines, and budgets.
4. Provide leadership in ensuring the integrity of clinical data regarding accuracy, accountability, documentation, and procedures through review of case report forms. Detect and prevent fraud and misconduct. Implement corrective actions when appropriate.
5. Assist the Director of Clinical Operations in planning and organizing key project milestones such as Investigators meetings, Safety Plans, BDRM, SAP, etc.
6. Develop and track a project budget under supervision, predicting costs and creating time-phased budgets to optimize turnaround times and costs. Manage internal and external partners, contracts, negotiations, and payments.
7. Lead the in-house study team when applicable. Coordinate activities of all team members including CTO and CTAs.
8. Lead CRAs, CTCs, and CTAs within the project team (in-house or outsourced). Validate skills of outsourced trial teams, conduct training, and serve as on-site coach for CRAs. Coordinate and steer activities, including site visits.
9. Manage CRO PM as the primary contact. Validate skills of outsourced trial teams, conduct training, and provide coaching.
10. Co-chair project TC with CRO and review minutes. Review monitoring visit reports in-house and outsourced.
11. Assist in audit reviews and CAPA plan preparations.
12. Lead IMP needs and supervise CTO or designee, IMP shipment activities, and liaise with logistics vendors as needed.
13. Assist in developing departmental SOPs, WIs, and study-specific procedures. Ensure compliance with SOPs, policies, ICH GCP, and regulatory guidelines.
14. Coordinate logistics activities for IMP availability, vendor contact, budget evaluation, and supervision of shipment activities.

Requirements :

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

They offer :

• Fixed Contract
• Flexible entry hours

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Research and Project Management
• Industries: Biotechnology, Pharmaceutical Manufacturing, Healthcare

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