Clinical Affairs Program Manager Italy

Chronos Consulting; Italia; Remoto; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading global medical device company seeks a Clinical Affairs Program Manager in Italy. This role involves developing strategies for clinical trials, managing approvals, and ensuring compliance with health regulations, with the potential for up to 40% travel. The ideal candidate will have extensive experience in clinical trial management within the biopharmaceutical sector.

Competenze

• At least 3 years in clinical management within biopharmaceutical, device industry, or CRO.
• Over 4 years of direct experience in clinical trial management.
• Expertise in GCP, ICH, and proven success in Phase I–III clinical trials.

Mansioni

• Collaborate with stakeholders to execute clinical trials and investigator-sponsored studies.
• Design clinical trials, including protocol development and regulatory discussions.
• Build and maintain relationships with investigators and key opinion leaders.

Conoscenze

Communication

Organizational skills

Program management

Financial skills

Knowledge of GCP guidelines

Clinical trial management

Proficiency in English

Formazione

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

Strumenti

Clinical trial management systems

Descrizione del lavoro

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Clinical Affairs Program Manager Italy, Italy

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Client:

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

e894c7f5b1b3

Job Views:

16

Posted:

14.06.2025

Expiry Date:

29.07.2025

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Job Description:

Job Description

Our client is a global medical device company, pioneer of MR-guided focused ultrasound technology, a game-changing innovation. They are seeking a Clinical Affairs Program Manager for 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 also include managing clinical trial approvals with local IRBs and/or Competent Authorities.

Required Skills and Experience:

1. BS, BA, BSN, RN, or higher degree in Life Sciences or related fields
2. At least 3 years in clinical management within biopharmaceutical, device industry, or CRO, with biopharmaceutical experience being a strong advantage
3. Over 4 years of direct experience in clinical trial management
4. Proven success in Phase I–III clinical trials
5. Expertise in GCP, ICH, ISO guidelines; FDA or Health Canada experience is a plus but not required
6. Experience managing Core Labs, data management, biostatistics, and safety reporting
7. Knowledge of electronic data capture and clinical trial management systems
8. Excellent communication, organizational, program management, and financial skills
9. Proficiency in English; additional languages are a plus
10. Ability to work independently and collaboratively
11. Willingness to travel up to 40% domestically and internationally

Responsibilities:

• Collaborate with stakeholders to execute clinical trials and investigator-sponsored studies
• Design clinical trials, including protocol development and discussions with EU authorities
• Manage investigator and vendor selection, contracting, and clinical trial approvals
• Develop budgets and ensure adherence to financial goals
• Interpret and document clinical results for regulatory submissions and publications
• Build and maintain relationships with investigators, researchers, and key opinion leaders
• Develop SOPs and work instructions to ensure compliance with GCP and other standards
• Ensure protocol adherence and regulatory compliance
• Identify training needs and develop training materials for staff and sites