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 ensure quality standards are maintained. Promote career development and accountability.
- Maintain routine 1:1 meetings with SSU personnel for task management and career growth.
- Serve as SME support for Site Start-up activities.
- Ensure SSU personnel work to high quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
- Ensure proper resources, training, and system access for SSU personnel.
- Contribute to training plan development and monitor training goals.
- Ensure administrative compliance (time entry, billing, expenses).
- Participate in hiring processes, including CV review and interviews.
- Support onboarding of new SSU personnel.
- Develop and maintain standards and processes for staff, ensuring consistent quality.
- Manage FTE allocation to align with project budgets and assess as needed.
- Provide ongoing feedback, coaching, and conduct performance reviews.
- Lead department meetings and internal initiatives.
- Perform other duties as assigned.
Qualifications:
- 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 process.
- People management skills and team collaboration experience.
- 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 Qualifications:
- Advanced degree in life sciences or related field.
- Experience in CRO environment.
- Demonstrated ability to influence, negotiate, and lead teams.
- Strong presentation and interpersonal skills.
- Ability to work with leadership to understand customer needs.
- Results-oriented with high integrity.
- Ability to inspire and lead teams effectively.
- Excellent time management and decision-making skills.
- Willingness to travel occasionally.
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