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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. Emphasizes 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 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 adhere to quality standards and compliance with SOPs, guidelines, project plans, and regulatory requirements.
- Ensure proper resources, training, and access for SSU personnel to meet their responsibilities.
- Contribute to training plan development and monitor training goals.
- Ensure compliance with administrative tasks such as time entry, billing, and expense reporting.
- Participate in hiring processes, including CV review and interviews.
- Support onboarding of new SSU personnel in collaboration with HR and training teams.
- Develop and maintain standards and processes for staff, ensuring consistent quality execution.
- Manage FTE allocation per project to align with budgets, with ongoing assessment and adjustments.
- Provide ongoing feedback, development, and coaching, including performance reviews.
- 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 proven competencies.
- Knowledge of GCP/ICH guidelines and clinical development process.
- People management skills.
- Experience with resource management and team environment.
- Proficiency with 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 thinking, and influence skills.
- High integrity, leadership, and motivational skills.
- Excellent presentation and communication skills.
- Willingness to travel occasionally.
Any 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. For accommodations, contact [email].
Note: Beware of fraudulent job offers; our organization will only extend offers after proper communication and interviews.