Permanent Positions

As a Clinical Study Manager, you will be responsible for leading and managing a cross-functional study team to ensure the successful delivery of clinical study activities within demanding timelines, budget, and quality standards.

Key Responsibilities:

• Provide leadership and management to the cross-functional clinical study team, ensuring that team objectives and responsibilities are fulfilled.
• Lead studies across phases I to III, taking on the role of Global Protocol Lead or Molecule Lead for smaller programs. Serve as the main point of contact for clinical site management.
• Build strong relationships with investigators, study site personnel, external service providers (ESPs), other external parties, and sponsor affiliates to ensure a thorough understanding of the patient’s medical needs, the current clinical landscape, and operational feasibility.
• Ensure the timely delivery of all clinical study activities in accordance with agreed-upon timelines, budget, and quality requirements.
• Lead and manage appointed ESPs, closely monitoring their performance, overseeing sponsor oversight activities, and managing ESP contracts, amendments, and change orders.
• Identify and manage risks to critical data and processes, implementing appropriate risk control measures to mitigate potential issues.
• Ensure proper management and reporting of protocol deviations, suspected serious breaches, and other non-conformances related to Good Clinical Practice (GCP).

Qualifications:

• University degree in Life/Health Sciences or a related field.
• Minimum of 5 years of experience in clinical project management, demonstrating a strong understanding of all aspects of the clinical study process.
• Proven experience in managing external service providers (ESPs) involved in clinical studies.
• Ability to lead and inspire multi-disciplinary teams, with strong skills in team building, negotiation, and conflict resolution.

Note: This is a remote position, allowing you to work from anywhere within Europe.