Social network you want to login/join with:
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. Emphasizes effective resourcing and personnel development. Provides oversight and leads activities for site start-up project delivery; coordinates inter-departmental and client communication; helps resolve administrative, personnel, and project issues.
Essential functions include but are not limited to:
- Develop, mentor, manage, and coach SSU personnel to maintain Precision’s quality standards.
- Advocate for individual career development and responsibility.
- 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, materials, and system access for SSU personnel.
- Contribute to training plan development and accountability.
- Ensure administrative tasks compliance (time entry, training, billing, expenses).
- Participate in interviewing and onboarding new SSU personnel.
- Develop and maintain standards and processes for staff, ensuring consistent quality.
- Participate in resourcing and FTE allocation per project.
- Provide ongoing feedback and conduct performance reviews.
- Lead 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 proven competencies.
- Knowledge of GCP/ICH guidelines and clinical development process.
- People management experience.
- Teamwork 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.
Competencies:
- Ability to collaborate with leadership and understand customer needs.
- Analytical skills and business acumen.
- Effective presentation skills.
- High integrity and ethical standards.
- Leadership and motivational skills.
- Results-oriented and adaptable.
- Influencing, negotiating, and conflict management skills.
- Time management and critical thinking.
- Excellent communication skills.
Occasional travel may be required. Data provided will be stored according to our Privacy Policy. For CA applicants, refer to our Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. We do not make employment decisions based on protected characteristics. For accommodations, contact [emailprotected]. Beware of fraudulent job offers. Our organization will not make job offers without proper communication and a formal interview process.