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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 the highest quality standards and maintain compliance with SOPs, guidelines, project plans, and regulatory requirements.
- Ensure SSU personnel have the resources, training, materials, and system access needed.
- Contribute to training plan development and hold personnel accountable for training goals.
- Ensure administrative tasks compliance (e.g., time entry, billing, expenses).
- Participate in the interview process for new SSU personnel and support onboarding.
- Contribute to development of standards and processes for staff and ensure consistent execution.
- Participate in resource planning and manage FTE allocation per project.
- Provide ongoing feedback, development, coaching, and conduct performance reviews.
- Lead department meetings and communicate high-level updates.
- 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 proven competencies.
- Knowledge of GCP/ICH guidelines and clinical development process.
- People management experience.
- Experience with resource management and team environment.
- 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, strategic thinker, and influencer.
- High integrity, leadership, and motivational skills.
- Results-oriented with strong presentation and communication skills.
- Willingness to travel occasionally.
Note:
Any data provided will be stored in accordance with our Privacy Policy. For CA applicants, please refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to protected characteristics. If you require accommodations, contact us at [email].
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