Position:
Director, Site Start up
Company:
Precision for Medicine
Location:
United Kingdom (Remote)
Short Summary:
Provides leadership to the Site Start-up (SSU) department, contributing to strategy and direction for implementation and expansion, ensuring compliance with regulatory requirements and client satisfaction.
Responsibilities:
- Provides SSU team with guidance, leadership, and overall support for project delivery.
- Supports management of site start-up delivery through oversight of various departments.
- Establishes the Precision for Medicine SSU framework for project execution and delivery.
- Collaborates with Clinical Operations and other departments for planning and execution of SSU activities.
- Acts as an ambassador for change management for PFM growth and expansion.
- Manages escalations and remediation of SSU concerns.
- Supports optimization of processes to meet budget targets.
- Ensures compliance with company policies and regulatory guidelines.
- Collaborates with Business Development for opportunity development and proposals.
- Develops, measures, and reports SSU KPIs for continuous improvement.
Requirement:
- Bachelor's degree in life sciences or related field.
- Minimum of 12 years in clinical research with extensive Site Start-up experience.
- Experience working for a Clinical Research Organisation (CRO).
- Expert knowledge of GCP/ICH guidelines and clinical development process.
- Demonstrated leadership track record and experience in resource management.
- Proficient in Microsoft Office and clinical software (CTMS, eTMF, EDC).
- Excellent communication, organizational skills, and attention to detail.
- Proven experience in strategic planning, risk management, and change management.
- Fluency in English.
Benefits:
- Precision for Medicine is an Equal Opportunity Employer.
- Commitment to quality, people, clients, and performance.