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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. 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 quality standards.
- Advocate for individual career development and accountability.
- Maintain routine 1:1 meetings with SSU personnel to manage tasks and career growth.
- Serve as SME support for Site Start-up activities.
- Ensure compliance with SOPs, guidelines, project plans, and regulatory requirements.
- Provide resources, training, and system access to SSU personnel.
- Contribute to training plan development and ensure training goals are met.
- Ensure administrative tasks compliance (time entry, billing, expenses).
- Participate in the interview process for new SSU personnel.
- Support onboarding in collaboration with HR and training teams.
- Develop standards and processes for staff and ensure consistent execution.
- Manage FTE allocation to align with project budgets.
- Provide ongoing feedback, development, and coaching.
- Lead department meetings for high-level communication.
- Assist with internal initiatives and perform 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 demonstrated competencies.
- Knowledge of GCP/ICH guidelines and clinical development.
Other Required:
- People management skills.
- Teamwork and resource management 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:
- Advanced degree in life sciences.
- Experience in CRO environment.
- Ability to work with leadership and understand customer needs.
- Analytical skills and business acumen.
- Strong presentation and negotiation skills.
- High integrity and leadership qualities.
- Ability to inspire and lead teams.
- Results-oriented with excellent time management.
- Travel flexibility.
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