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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, with an emphasis 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.
- Advocate for individual career development and responsibility/accountability.
- 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 hold personnel accountable for training goals.
- Ensure administrative compliance (time entry, billing, expenses).
- Participate in interviewing and onboarding new SSU personnel.
- Contribute to standard and process development for staff and ensure consistent execution.
- Participate in resource planning and FTE allocation per project.
- Provide ongoing feedback, development, and coaching, including performance reviews.
- Lead department meetings for high-level communication.
- Support internal initiatives and perform other duties as assigned.
Qualifications:
- Bachelor's degree in life sciences or related field, or equivalent experience.
- Minimum 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 experience and resource management skills.
- 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, analytical skills, and business acumen.
- Strong presentation and communication skills.
- Ability to lead, inspire, and create ownership environment.
- Results-oriented, accountable, and flexible.
- Proven influence, negotiation, and conflict management skills.
- Excellent time management and decision-making skills.
- Occasional travel may be required.
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