Manager, Clinical Monitoring

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

Descrizione del lavoro

An established industry player is seeking a Manager for Clinical Monitoring to lead a team of Clinical Research Associates. This pivotal role involves optimizing clinical research services, mentoring staff, and ensuring adherence to high standards of quality in oncological trials. The ideal candidate will possess extensive experience in clinical operations and a deep understanding of regulatory standards. This remote position offers the opportunity to make a significant impact in clinical research while fostering team development and enhancing employee satisfaction. Join a forward-thinking organization committed to excellence in healthcare.

Competenze

• Minimum 7 years in clinical operations with 5 years onsite monitoring experience.
• Strong monitoring experience in oncological clinical trials.

Mansioni

• Develop action plans to optimize CRA services ensuring high-quality delivery.
• Mentor and manage CRA staff to maintain quality standards.

Conoscenze

ICH-GCP

People Management

Clinical Research Operations

Problem Solving

Electronic Data Capture Systems

Communication Skills

Formazione

Graduate or Postgraduate Degree in a Scientific or Healthcare Discipline

Strumenti

EMRs

EDCs

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) offers a development path for clinical research professionals. Responsibilities include 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) to uphold Precision for Medicine’s standards of quality. The focus is on resource allocation, providing CRAs with necessary tools, and supporting their career development to reduce turnover and enhance employee satisfaction.

Essential functions include but are not limited to :

1. Develop action plans and oversee strategies to optimize CRA services, ensuring high-quality delivery of goals.
2. Assist in project resourcing, ensuring proper resource allocation and updating tracking systems.
3. Collaborate with Clinical Team Leads, Clinical Trial Managers, and Clinical Operations Management to meet resource and site needs.
4. Mentor, manage, and coach CRA staff, supporting their skills development and maintaining quality standards.
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 resources, training, and access to systems needed for their roles.
8. Maintain accurate administrative updates and participate in improving CRA procedures.
9. Develop metrics for CRA oversight and evaluate these with the management team.
10. Participate in the interview process for new CRAs and conduct onboarding training.
11. Represent Precision for Medicine professionally and manage CRA staff according to company policies.
12. Contribute to planning, work assignment, and performance feedback.
13. Perform other duties as assigned.

Qualifications :

• Graduate or postgraduate degree 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 use of electronic data capture systems.
• Strong monitoring experience in oncological clinical trials.
• 3-5 years of supervisory experience managing CRAs, including developing staff 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 able to work independently or in teams.
• Excellent problem-solving, prioritization, and communication skills.
• Commitment to continuous improvement and professionalism.

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We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.

If you require accommodations to complete the application process, please contact us at [email protected].

Beware of fraudulent job offers. Our organization will only extend offers through verified communication channels following a formal interview process.

Location: Clinical Manager • Varese, Lombardy, ITALY