Precision for Medicine is growing! We are hiring a Manager, Clinical Monitoring based in Italy. The position can be fully remote.
Position Summary :
- The Manager of Clinical Monitoring (GCM) offers a development path for clinical research professionals, focusing on managing and developing the organization’s Clinical Research Associate (CRA) workforce and supporting departmental initiatives to improve quality and productivity.
- This role requires the ability to lead, manage, and motivate a team of CRAs (employees and/or consultants) to uphold Precision for Medicine’s standards of quality. The manager will ensure proper resource allocation, provide career development support, and aim to minimize turnover while maintaining high employee satisfaction.
Essential functions include but are not limited to :
- Develop action plans and oversee strategies to optimize CRA services, ensuring high-quality delivery aligned with departmental goals.
- Assist with project resourcing, update tracking systems, and coordinate with project teams.
- Collaborate with clinical leads and management to meet resource and site requirements.
- Mentor and manage CRA staff, fostering skill development and maintaining quality standards.
- Conduct site visits to assess CRA skills and address project-specific issues.
- Identify quality risks, recommend corrective actions, and address employee performance issues.
- Ensure staff have necessary resources, training, and access to systems.
- Maintain accurate administrative updates and participate in improving CRA procedures.
- Develop metrics for CRA oversight and evaluate performance.
- Participate in hiring processes, including CV review and interviews.
- Conduct onboarding training for new staff.
- Represent the company professionally and manage staff according to company policies.
- Assist with planning, work assignment, and performance feedback.
- Perform additional duties as assigned by leadership.
Qualifications :
- Graduate or postgraduate degree in a scientific or healthcare discipline or equivalent experience.
- Minimum 7 years in clinical operations or related fields, with at least 5 years onsite monitoring experience, including use of electronic data capture systems.
- Strong monitoring experience in oncological trials.
- 3-5 years of supervisory experience managing CRAs, including developing training programs and evaluation processes.
- Willingness to travel domestically and internationally (~25%).
Skills and Competencies :
- Mastery of ICH-GCP, local regulations, SOPs, and knowledge of all study phases.
- High emotional intelligence and passion for people management.
- Ability to develop training plans and ensure staff meet training goals.
- Deep understanding of clinical research operations and site management.
- Proficiency with EMRs and EDCs.
- Self-motivated, organized, and able to work independently and in teams.
- Excellent problem-solving and prioritization skills.
- Commitment to continuous improvement and professionalism.
- Ability to deliver formal presentations effectively.
We value diversity and are an equal opportunity employer. For applicants with disabilities, accommodations are available upon request. Beware of fraudulent job offers; our hiring process involves direct communication with our recruitment team and a formal interview.