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Job Reference:
8292217676768477184327664
Job Views:
1
Posted:
18.06.2025
Expiry Date:
02.08.2025
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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, focusing 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:
- Develop, mentor, manage, and coach SSU personnel to ensure 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 comply with SOPs, guidelines, project plans, and regulatory requirements.
- Ensure proper resources, training, and access to systems for SSU personnel.
- Contribute to training plans and ensure training goals are met.
- Ensure compliance with administrative tasks such as time entry, training, billing, and expense reporting.
- Participate in the interview process for new SSU personnel and support onboarding training.
- Contribute to developing standards and processes for staff and ensure consistent execution.
- Manage FTE allocation per project to align with budgets, with ongoing assessment and adjustment.
- Provide ongoing feedback, development, and coaching to line reports, including performance reviews.
- Participate in department meetings for high-level communication.
- Assist with internal initiatives and perform other duties as assigned.
Qualifications:
- Bachelor's degree in life sciences or related field or equivalent experience.
- Minimum 6 years in clinical research with extensive Site Start-up experience.
- Leadership experience or proven competencies.
- Knowledge of GCP/ICH guidelines and clinical development.
- Experience in people management, team environment, resource management.
- Proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC).
- Strong communication, organizational skills, and attention to detail.
- Strategic planning, risk management, and change management experience.
- Fluency in English.
Preferred:
- Advanced degree in life sciences or related field.
- Experience in CRO environment.
Competencies include:
- Understanding customer needs, analytical skills, business acumen.
- Effective presentation and communication skills.
- High integrity, leadership, and team inspiration.
- Ability to create ownership and drive productivity.
- Results-oriented, accountable, flexible.
- Conflict management, time management, negotiation skills.
- Strong verbal and written communication skills.
- Occasional travel may be required.
Any data provided will be stored according to our Privacy Policy. For CA applicants, see CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to characteristics protected by law. If you require accommodation, contact [emailprotected].