Full-Time Site Start Up Manager

Position Summary: Manages and oversees daily activities of Site Start-up (SSU) personnel, adhering to SOPs, regulatory directives, and study plans. Focuses on effective personnel resourcing and development. Provides oversight and leadership for site start-up project delivery, coordinates inter-departmental and client communication, and resolves administrative, personnel, and project issues.

Essential Functions:

1. Develop, mentor, manage, and coach SSU personnel to uphold Precision's quality standards.
2. Advocate for individual career development and ensure individual responsibility/accountability.
3. Conduct routine 1:1 meetings to manage tasks and support career development.
4. Provide SME support for Site Start-up activities.
5. Ensure SSU personnel maintain the highest quality standards, comply with SOPs, guidelines, project plans, and regulatory requirements.
6. Ensure SSU personnel have the necessary resources, training, materials, and system access.
7. Contribute to training plan development and hold personnel accountable for achieving goals.
8. Ensure SSU personnel comply with administrative tasks (e.g., time entry, corporate training, time/billing compliance, travel expenses).
9. Participate in the interview process for new SSU personnel (CV review, interviews).
10. Support onboarding training for new personnel with HR, Training, and other departments.
11. Develop robust standards and processes for consistent quality execution among SSU personnel.
12. Actively participate in SSU personnel resourcing and FTE allocation to align time/work billed with project budgets, adjusting as needed.
13. Provide ongoing feedback, development, and coaching, including annual performance reviews.
14. Participate in department meetings for high-level communication.
15. Assist with internal initiatives.
16. Perform other duties as assigned.

Qualifications:

• Bachelor's degree in life sciences or related field or equivalent experience.
• Minimum 6 years in clinical research, including extensive Site Start-up experience.
• Leadership experience or proven competencies.
• Knowledge of GCP/ICH guidelines and the clinical development process.
• Competence in people management.
• Teamwork and resource management experience.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and clinical software (CTMS, eTMF, EDC).
• Strong communication, interpersonal, organizational skills, attention to detail, and customer service orientation.
• Experience in strategic planning, risk management, and change management.
• Fluency in English.
• (Preferred) Advanced degree in life sciences.
• (Preferred) CRO environment experience.
• (Preferred) Ability to work closely with business unit leadership to understand customer needs.
• (Preferred) Demonstrated analytical skills and business acumen.
• (Preferred) Strong presence and ability to confidently deliver presentations.
• (Preferred) High level of integrity, inspiring high professional and ethical standards.
• (Preferred) Ability to lead and inspire excellence within a team.
• (Preferred) Ability to create an environment fostering employee ownership, productivity, and efficiency.
• (Preferred) Results-oriented, accountable, motivated, and flexible.
• (Preferred) Proven ability to effectively influence, negotiate, and manage conflict.
• (Preferred) Excellent time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills.
• (Preferred) Strong presentation, verbal, and written communication skills.

Occasional travel may be required.

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