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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.
- 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 high-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 tasks are completed accurately (e.g., time entry, billing, expense reporting).
- Participate in interviews for new SSU personnel and support onboarding processes.
- Develop and maintain standards and processes for staff, ensuring quality execution.
- Manage FTE allocation per project, aligning work with budgets.
- Provide ongoing feedback, development, and coaching, including performance reviews.
- Participate in department meetings and internal initiatives.
- 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, including extensive Site Start-up experience.
- Leadership experience or demonstrated competencies.
- Knowledge of GCP/ICH guidelines and clinical development process.
- People management skills.
- Experience with resource management and team environments.
- Proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC, etc.).
- 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:
- Ability to work with leadership to understand customer needs.
- Strong analytical skills and business acumen.
- Confident presentation skills.
- High integrity and ethical standards.
- Leadership and team inspiration ability.
- Ownership and productivity enhancement.
- Results-oriented, accountable, flexible.
- Conflict management, negotiation, and interpersonal skills.
- Excellent communication skills.
- Occasional travel may be required.
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