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. 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 include but are not limited to:
- Develop, mentor, manage, and coach SSU personnel to ensure quality standards are maintained. Advocate for career development and 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 according to quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
- Ensure proper resources, training, and access are provided to SSU personnel.
- Contribute to training plan development and hold personnel accountable for training goals.
- Ensure administrative tasks are completed accurately (time entry, billing, expenses).
- Participate in interviewing and onboarding new SSU personnel.
- Develop standards and processes for staff and ensure consistent execution.
- Manage FTE allocation per project, aligning work with budgets, and adjust as needed.
- Provide ongoing feedback, development, and coaching to line reports, including performance reviews.
- Conduct department meetings for high-level communication.
- Assist with 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 with extensive Site Start-up experience.
- Leadership experience or proven competencies.
- Knowledge of GCP/ICH guidelines and clinical development process.
- People management skills, resource management experience, and proficiency with Microsoft Office and clinical software (CTMS, eTMF, EDC).
- Strong communication, organizational, and interpersonal skills. Ability to plan strategically, manage risks, and adapt to change. Fluency in English.
Preferred:
- Advanced degree in life sciences or related field.
- Experience in CRO environment.
- Demonstrated ability to work with leadership, influence, negotiate, and lead teams.
- High integrity, results-oriented, and capable of inspiring excellence.
- Strong presentation and communication skills. Occasional travel may be required.
Data provided will be stored according to our Privacy Policy. For CA applicants, 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 accommodation during the application process, contact us at [email]. Be cautious of fraudulent job offers; our organization will only extend offers after proper communication and a formal interview process.