Clinical Study Manager (Pharmaceutical, Remote)

Job summary

Responsible for overseeing the delivery of clinical studies within a designated region or country, ensuring quality and compliance with timelines and budgets. This role involves leading a clinical operations team and collaborating with various stakeholders to achieve study objectives.

Qualifications

• Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred.
• Minimum of 7 years of experience in clinical research within the biotech, pharmaceutical, or CRO industry, including 2 years in clinical study management or team lead roles.
• Experience as a Clinical Research Associate (CRA) is preferred.

Responsibilities

• Lead the regional/country clinical operations team and external vendors to ensure effective study delivery.
• Manage planning and execution of clinical studies from feasibility to closeout, ensuring alignment with global timelines.
• Generate and maintain study start-up and recruitment timelines, tracking progress and ensuring operational feasibility.
• Collaborate with stakeholders to ensure timely submission of study documents to regulatory authorities.
• Monitor study activities for compliance with protocols and regulations, ensuring inspection readiness.
• Manage regional/country study budgets and resource needs, liaising with functional managers as necessary.

Skills

• Strong leadership and decision-making abilities.
• Excellent communication and collaboration skills.
• Proficiency in MS Office and project planning applications.

Education

• Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred.

Tools

• MS Office, Project Planning Applications.