Manager, Clinical Monitoring

Precision for Medicine; Roma; Remoto; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading company in clinical research is seeking a Manager for Clinical Monitoring. This role involves managing a team of Clinical Research Associates, ensuring high-quality service delivery, and fostering career development. Candidates should have a strong background in clinical operations, particularly in oncological trials, and possess excellent people management skills.

Competenze

• At least 7 years in clinical operations with 5 years onsite monitoring experience.
• Strong background in oncological trials and electronic data capture systems.
• Willingness to travel domestically and internationally (~25%).

Mansioni

• Manage and develop the CRA workforce, ensuring high-quality delivery.
• Conduct site visits and mentor CRA staff.
• Oversee CRA recruitment and onboarding processes.

Conoscenze

People management

Emotional intelligence

Training program development

Formazione

Graduate or postgraduate degree in a scientific or healthcare discipline

Descrizione del lavoro

Precision for Medicine is growing! We are hiring:

• Manager, Clinical Monitoring
• Based in Italy. The position could be fully remote.

Position Summary

The Manager, Clinical Monitoring (GCM) provides a development pathway for clinical research professionals. Responsibilities include managing and developing the organization's Clinical Research Associate (CRA) workforce and supporting departmental initiatives to enhance quality and productivity. The role requires leading, managing, and motivating a team of CRAs to meet company standards, ensuring proper resource allocation, and fostering career development to reduce turnover and maintain high employee satisfaction.

Essential Functions

1. Develop action plans and oversee strategies to optimize CRA services, focusing on high-quality delivery and goal achievement.
2. Assist with project resourcing, ensuring appropriate resource allocation and updating tracking systems.
3. Collaborate with Clinical Team Leads and Management to meet resource and site requirements.
4. Mentor and coach CRA staff to uphold quality standards and support career development.
5. Conduct site visits to assess CRA skills and address developmental needs.
6. Identify quality risks, recommend corrective actions, and address performance deficiencies.
7. Ensure staff have necessary resources, training, and system access.
8. Maintain accurate administrative updates and contribute to process improvements.
9. Develop metrics for CRA oversight and collaborate on their evaluation.
10. Participate in CRA recruitment, including CV review and interviews.
11. Oversee onboarding and training for new CRA staff.
12. Represent the company professionally.
13. Manage staff in alignment with company policies and values.
14. Assist with planning, assigning work, and providing performance feedback.
15. Perform additional duties as assigned.

Qualifications

Graduate or postgraduate degree in a scientific or healthcare discipline, or equivalent experience. At least 7 years in clinical operations or related fields, with a minimum of 5 years onsite monitoring experience, including electronic data capture systems and medical records. Strong monitoring background in oncological trials. Experience in staff development, evaluation, and training. Willingness to travel domestically and internationally (~25%).

Skills and Competencies

Mastery of ICH-GCP, local regulations, SOPs, and all study phases. High emotional intelligence, people management skills, and ability to develop training programs. Ability to develop training plans, hold personnel accountable, and manage remote monitoring and data review processes.