Clinical Affairs Program Manager Spain

buscojobs España; Valladolid; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading global medical device company is seeking a Clinical Affairs Program Manager to execute clinical trials across Europe. The role requires strategic planning for clinical trials, managing approvals, and collaborating with stakeholders. Ideal candidates will have a strong background in clinical management and excellent communication skills, along with a willingness to travel up to 40%.

Formación

• At least 3+ years in a clinical management role.
• Proven success in executing Phase I–III clinical trials.

Responsabilidades

• Collaborate with stakeholders to execute clinical trials.
• Manage investigator and site selection, contracting, and vendor relationships.
• Develop and manage budgets for clinical projects.

Conocimientos

Communication

Organizational Skills

Program Management

Financial Skills

Team Player

Educación

BS, BA, BSN, RN or higher degree in Life Sciences

Herramientas

Electronic Data Capture Systems

Clinical Trial Management Tools

Descripción del empleo

Clinical Affairs Program Manager Spain, Spain
Client : Location : Spain, Spain

Job Category : Other

EU work permit required :

Job Views :

Posted :

25.04.2025

Expiry Date : 09.06.2025

Our client is a global medical device company, pioneer of MR-guided focused ultrasound technology, a groundbreaking innovation. They are seeking a Clinical Affairs Program Manager Europe. The role is primarily remote, with up to 40% travel, based in Europe.

As part of the global clinical affairs team, you will develop strategies for executing clinical trials that demonstrate the safety and efficacy of medical products. Responsibilities include managing clinical trial approvals with local IRBs and/or Competent Authorities.

Required Skills and Experience :

• BS, BA, BSN, RN, or higher degree in Life Sciences or related disciplines
• At least 3+ years in a clinical management role within the biopharmaceutical or device industry, Clinical Research Organization; biopharmaceutical experience is a strong advantage
• Additional 4+ years of direct experience in clinical trial management
• Proven success in executing Phase I–III clinical trials
• Deep knowledge of GCP, ICH, ISO guidelines; FDA or Health Canada experience is a plus but not required
• Hands-on experience managing Core Labs, data management, biostatistics, and safety reporting
• Familiarity with electronic data capture systems and clinical trial management tools
• Excellent communication, organizational, program management, and financial skills
• Fluency in English; additional languages are a plus
• Team player with the ability to work independently
• Willingness and ability to travel up to 40% domestically and internationally

Responsibilities :

• Collaborate with stakeholders to execute clinical trials and investigator-sponsored studies
• Design clinical trials, develop protocols, and manage discussions with EU authorities
• Manage investigator and site selection, contracting, and vendor relationships
• Secure IRB/EC approvals, oversee site initiation, patient recruitment, and enrollment; address issues proactively
• Develop and manage budgets for clinical projects
• Interpret and document clinical results for regulatory submissions and publications
• Build and maintain collaborations with investigators, researchers, and key opinion leaders
• Develop SOPs and work instructions to ensure compliance with GCP standards
• Ensure adherence to protocols and regulatory guidelines
• Identify training needs and develop training materials for internal and external use

Please note that if you do not hold a passport for the country of the vacancy, a work permit may be required. For more information, check our Blog.

Do not include bank or payment details when applying. Applications should be submitted via the 'Apply now' button.

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