Manager, Clinical Monitoring

Buscojobs; Umbria; Remoto; EUR 60.000 - 100.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Manager of Clinical Monitoring to lead a team of Clinical Research Associates. This fully remote position offers a unique opportunity to shape the future of clinical research operations. You will be responsible for developing and executing strategies that enhance the quality and productivity of CRA services. Your leadership will be crucial in mentoring staff, optimizing resource allocation, and ensuring compliance with industry standards. If you are passionate about clinical research and have a proven track record in team management, this role offers a chance to make a significant impact.

Competenze

• 7+ years in clinical operations with 5 years onsite monitoring experience.
• Strong background in managing CRAs and developing training processes.

Mansioni

• Lead and manage a team of CRAs, ensuring high-quality delivery of goals.
• Conduct site visits and mentor CRA staff to maintain quality standards.

Conoscenze

Clinical Operations Management

Oncological Trials Monitoring

ICH-GCP Compliance

EMRs and EDCs Proficiency

Team Leadership

Training Development

Communication Skills

Formazione

Graduate or Postgraduate Degree in Scientific or Healthcare Discipline

Descrizione del lavoro

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) provides 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 independently lead, manage, and motivate a team of CRAs (employees and/or consultants), ensuring resources are appropriately allocated and staff are well-supported for success. It also involves career development and employee satisfaction enhancement.

Essential functions include but are not limited to:

• Develop action plans and oversee strategies to optimize CRA services, ensuring high-quality delivery of goals.
• Assist in project resourcing, update tracking systems, and coordinate with project teams.
• Collaborate with clinical leads and management to meet resource and site requirements.
• Mentor, manage, and coach 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 performance issues.
• Ensure staff have necessary resources, training, and access to systems.
• Maintain accurate administrative updates and improve CRA procedures.
• Develop metrics for CRA oversight and participate in their evaluation.
• Participate in CRA hiring processes and onboarding training.
• Represent the company professionally and manage staff according to company policies.
• Support planning, work assignment, and performance feedback processes.
• Perform additional duties as assigned.

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, including electronic and paper medical records.
• Strong monitoring experience in oncological trials.
• 3-5 years of direct supervisory experience managing CRAs, including developing training and evaluation processes.
• Willingness to travel domestically and internationally (~25%).

Skills and Competencies:

• Mastery of ICH-GCP, local regulations, SOPs, and clinical study phases.
• High emotional intelligence and people management skills.
• Ability to develop training plans and hold personnel accountable.
• Deep understanding of clinical research operations and problem-solving at the site level.
• Proficiency with EMRs and EDCs.
• Self-motivated, organized, and team-oriented.
• Excellent communication and presentation skills.

We respect your privacy. For more information, see our Privacy Policy and CA Privacy Notice. We are an Equal Opportunity Employer and committed to diversity and inclusion. If you need accommodations during the application process, contact us at [emailprotected].