Job Description
Position Summary:
Manages and oversees the day-to-day activities of Site Start-up (SSU) personnel in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans. Focuses on effective resourcing and personnel development. Provides oversight and leadership for site start-up project delivery; coordinates inter-departmental and client communication; and helps resolve administrative, personnel, and project issues.
Essential Functions:
- Develop, mentor, manage, and coach SSU personnel to maintain Precision’s quality standards.
- Advocate for individual career development and responsibility.
- Maintain routine 1:1 meetings with SSU personnel for task management and career development.
- Serve as SME support for Site Start-up activities.
- Ensure SSU personnel work to the highest quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
- Ensure SSU personnel have proper resources, training, and access to systems.
- Contribute to training plan development and monitor training goals.
- Ensure administrative compliance (time entry, billing, expenses).
- Participate in interviews for new SSU personnel and support onboarding.
- Contribute to developing standards and processes for staff.
- Manage FTE allocation per project, aligning work with budgets.
- Provide ongoing feedback, coaching, and performance reviews.
- Participate in department meetings and internal initiatives.
- 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 Site Start-up experience.
- Leadership experience or proven competencies.
- Knowledge of GCP/ICH guidelines and clinical development.
- People management experience.
- Experience with resource management and team environment.
- Proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC).
- Strong communication, organizational, and interpersonal skills.
- Experience in strategic planning, risk, and change management.
- Fluency in English.
Preferred:
- Advanced degree in life sciences or related field.
- Experience in CRO environment.
Competencies:
- Customer needs understanding.
- Analytical skills and business acumen.
- Effective presentation skills.
- High integrity and ethical standards.
- Leadership and team inspiration.
- Ownership and productivity enhancement.
- Results-oriented, accountable, flexible.
- Conflict management and negotiation skills.
- Time management and decision-making skills.
- Excellent communication skills.
- Ability to travel occasionally.
Data will be stored in accordance with our Privacy Policy. For CA applicants, refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer.