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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; and helps resolve administrative, personnel, and project issues.
Essential Functions:
- Develops, mentors, manages, and coaches SSU personnel to ensure quality standards are maintained. Advocates for individual career development and responsibility.
- Maintains routine 1:1 meetings with SSU personnel to manage tasks and career growth.
- Serves as SME support for Site Start-up activities.
- Ensures SSU personnel work to high-quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
- Ensures proper resources, training, materials, and system access for SSU personnel.
- Contributes to training plan development and monitors training achievement.
- Ensures administrative compliance (e.g., time entry, billing, expenses).
- Participates in interviewing and onboarding new SSU personnel.
- Supports development of standards and processes, ensuring consistency and quality.
- Participates in resource planning and FTE allocation to align with project budgets.
- Provides ongoing feedback, coaching, and performance reviews.
- Conducts department meetings for high-level communication.
- Supports internal initiatives and performs 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.
Other Required:
- People management skills.
- Experience working in teams and 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.
- Confidence in delivering presentations.
- High integrity and ethical standards.
- Leadership and motivational skills.
- Ability to foster ownership and productivity.
- Results-oriented, accountable, flexible.
- Influence, negotiation, conflict management skills.
- Time management, decision-making, critical thinking.
- Excellent communication skills.
Occasional travel may be required. Data provided will be stored according to our Privacy Policy. For CA applicants, see 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 not make offers without prior communication, a recruiter, and a formal interview process.