Manager, Clinical Monitoring

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

Descrizione del lavoro

An established industry player is seeking a Manager for Clinical Monitoring to lead and develop a team of Clinical Research Associates. This pivotal role emphasizes enhancing quality and productivity within clinical research operations. The ideal candidate will possess extensive experience in clinical operations, particularly in oncological trials, and demonstrate strong leadership skills. This position offers the opportunity to shape the CRA workforce, ensuring high-quality delivery and supporting career development. Join a forward-thinking company dedicated to innovation and excellence in clinical research, where your contributions will make a significant impact.

Competenze

• 7+ years in clinical operations with 5 years of onsite monitoring experience.
• Strong experience in managing Clinical Research Associates (CRAs).

Mansioni

• Manage and develop the CRA workforce to enhance quality and productivity.
• Collaborate with Clinical Team Leads to meet resource and site requirements.

Conoscenze

Leadership

Clinical Operations

Oncological Trials Monitoring

Interpersonal Skills

Problem Solving

Training Development

Formazione

Graduate or Postgraduate Degree in Scientific or Healthcare Discipline

Strumenti

Electronic Medical Records (EMRs)

Electronic Data Capture (EDCs)

Descrizione del lavoro

Precision for Medicine is growing! We are hiring

Manager, Clinical Monitoring

based in Italy. The position could be covered fully remotely.

Position Summary :

The Manager, Clinical Monitoring (GCM) offers an advanced development path 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.

This role requires independent leadership, management, and motivation of a team of CRAs (employees and/or consultants) aligned with Precision for Medicine’s values and quality standards. The focus is on resource allocation, providing tools for success, and supporting CRA career development to reduce turnover and boost employee satisfaction.

Essential functions include but are not limited to :

1. Generate action plans and oversee strategies to optimize CRA services, ensuring high-quality delivery of goals.
2. Assist with project resourcing, ensuring appropriate resource allocation and updating tracking systems.
3. Collaborate with Clinical Team Leads, Clinical Trial Managers, and Clinical Operations to meet resource and site requirements.
4. Develop, mentor, manage, and coach CRA staff to uphold quality standards and support career growth.
5. Perform site visits to assess CRA skills and address project-specific issues.
6. Identify quality risks, recommend corrective actions, and address performance deficiencies.
7. Ensure staff have necessary resources, training, and system access.
8. Ensure timely and accurate administrative updates by CRAs.
9. Work with the Clinical Operations Management Team to improve CRA procedures and expectations.
10. Develop and maintain metrics for CRA oversight and evaluate them regularly.
11. Participate in interviewing and onboarding new CRAs.
12. Represent the company professionally.
13. Manage CRA staff in accordance with company policies and values.
14. Contribute to planning, work assignment, and performance feedback processes.
15. Perform other duties as assigned.

Qualifications :

• Graduate or postgraduate degree, preferably in a scientific or healthcare discipline, or equivalent experience.
• At least 7 years in clinical operations, data management, or related fields, with a minimum of 5 years onsite monitoring experience, including electronic data capture and medical records.
• Strong monitoring experience in oncological trials.
• 3-5 years of direct supervisory experience managing CRAs.
• Experience creating development programs, evaluation processes, and training clinical staff.
• Willingness to travel domestically and internationally (~25%).

Skills and Competencies :

• Mastery of ICH-GCP, local regulations, SOPs, and clinical study phases, including remote monitoring and data review.
• High emotional intelligence and passion for people management.
• 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 able to work independently and in teams.
• Strong interpersonal, presentation, and communication skills.
• Focus on continuous improvement and efficiency.

Additional notes on data privacy and equal opportunity employment are included, along with contact information for accommodations and fraud prevention warnings.