Director, Site Start up

Position Summary:

• Provides leadership to the Site Start-up (SSU) department and contributes to the strategy and direction of its implementation and expansion.
• Collaborates with other functions to secure SSU delivery and client satisfaction on activities like Informed Consent Form review and regulatory submissions.
• Works closely with the Head of Site Start Up on ongoing development and ensures compliance with regulatory requirements and ICH Guidelines.

Essential Functions:

• Provides SSU team with guidance, leadership, and support to meet client and departmental targets.
• Supports the overall management of site start-up delivery through direct management or cross-functional oversight.
• Works with the Head of Site Start Up to establish the PFM SSU framework and supports collaboration with Clinical Operations and project management.

Qualifications:

• Bachelor's degree in life sciences or related field with a minimum of 12 years in clinical research and extensive Site Start-up experience.
• Experience working for a Clinical Research Organisation (CRO) and proven people management experience.
• Expert knowledge of GCP/ICH guidelines, clinical development process, and proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC).