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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 leads activities for site start-up project delivery; coordinates inter-departmental and client communication; and helps resolve administrative, personnel, and project issues.
Essential functions of the job include but are not limited to:
- Develop, mentor, manage, and coach SSU personnel to ensure Precision’s 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 proper resources, training, materials, and system access for SSU personnel.
- Contribute to training plan development and hold personnel accountable for training goals.
- Ensure compliance with administrative tasks, including time entry, training, billing, and expense reporting.
- Participate in the interview process for new SSU personnel, including CV review and interviews.
- Support onboarding training for new personnel in collaboration with HR and other departments.
- Develop standards and processes for staff and ensure consistent, quality execution.
- Participate in resource planning and manage FTE allocation per project, adjusting as needed.
- 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.
Other Required:
- People management skills.
- Experience working in team environments with resource management.
- 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 work with leadership to understand customer needs.
- Analytical skills and business acumen.
- Strong presence and presentation skills.
- High integrity and ethical standards.
- Leadership and team inspiration abilities.
- Ownership and productivity focus.
- Results-oriented, accountable, flexible.
- Effective influencing, negotiation, conflict management.
- Excellent communication skills.
- Willingness to travel occasionally.
Any data provided as part of this application will be stored in accordance with 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 accommodations due to disability, contact us at [emailprotected].
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