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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. Focuses on effective resourcing and personnel development. Provides oversight and leadership 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. Promote 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 for training goals.
- Ensure administrative compliance (time entry, training, billing, expenses).
- Participate in the interview process for new SSU personnel, including CV review and interviews.
- Support onboarding in collaboration with HR and training teams.
- Develop and maintain standards and processes for staff, ensuring consistent quality.
- Manage FTE allocation per project, aligning with budgets and adjusting as needed.
- Provide ongoing feedback, coaching, and conduct 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, including extensive Site Start-up experience.
- Leadership experience or proven competency.
- Knowledge of GCP/ICH guidelines and clinical development process.
- People management skills.
- Experience with team 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 collaborate with leadership and understand customer needs.
- Analytical skills and business acumen.
- Confident presentation skills.
- High integrity and ethical standards.
- Leadership and team inspiration abilities.
- Ownership and productivity focus.
- Results-oriented, accountable, flexible.
- Influencing, negotiating, conflict management skills.
- Time management, critical thinking, decision-making, interpersonal skills.
- Strong verbal and written communication skills.
Occasional travel may be required. Data collected will be stored according to privacy policies. We are an Equal Opportunity Employer. For accommodations, contact [email]. Beware of fraudulent job offers unrelated to our organization.