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; helps resolve administrative, personnel, and project issues.
Essential Functions:
- Develops, mentors, manages, and coaches SSU personnel to maintain quality standards. Advocates for career development and accountability.
- Maintains routine 1:1 meetings with SSU personnel for task management and career development.
- Serves as SME support for Site Start-up activities.
- Ensures SSU personnel work to high standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
- Provides resources, training, and access to systems for personnel.
- Contributes to training plan development and monitors training achievement.
- Ensures administrative compliance (e.g., time entry, billing, expenses).
- Participates in interviewing and onboarding new SSU personnel.
- Supports development of standards and processes for staff and ensures consistent execution.
- Participates in resource planning and FTE allocation to align with project budgets.
- Provides ongoing feedback, development, and coaching; conducts performance reviews.
- Leads department meetings for high-level communication.
- Performs other duties as assigned.
Qualifications:
Minimum Required:
- Bachelor's degree in life sciences or related field, or equivalent experience.
- At least 6 years in clinical research with extensive Site Start-up experience.
- Leadership experience or proven competencies.
- Knowledge of GCP/ICH guidelines and clinical development.
Other Required:
- People management skills.
- Experience with resource management.
- 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.
- Ability to work with leadership, deliver presentations, and influence others.
- High integrity, leadership, and team inspiration skills.
- Results-oriented with excellent time management and negotiation skills.
- Occasional travel may be required.
Any data provided 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. We do not extend job offers without proper communication and a formal interview process. Beware of fraudulent job offers; our organization will not make offers without prior contact with our recruiting team.