Manager, Clinical Monitoring

Buscojobs; Toscana; Remoto; EUR 50.000 - 90.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Manager for Clinical Monitoring to lead a dedicated team of Clinical Research Associates. This pivotal role focuses on enhancing the quality of clinical research services while fostering professional development within the team. You will be responsible for implementing effective strategies, mentoring staff, and ensuring compliance with industry standards. If you have a passion for clinical research and a strong background in operations, this opportunity offers the chance to make a significant impact in a dynamic environment where your leadership will drive success and innovation.

Competenze

• 7+ years in clinical operations with 5 years onsite monitoring experience.
• Mastery of ICH-GCP and local regulations.

Mansioni

• Manage and develop the CRA workforce to uphold quality standards.
• Conduct site visits and mentor CRA staff for career growth.

Conoscenze

Clinical Operations

Data Management

Oncological Clinical Trials

People Management

Problem-Solving

Training Development

Formazione

Degree in a Scientific or Healthcare Discipline

Strumenti

Electronic Data Capture Systems

Electronic Medical Records

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 :

1. The Manager of 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.
2. 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 will be on resource allocation, providing tools for success, and supporting CRA career development to reduce turnover and boost satisfaction.

Essential functions include but are not limited to :

1. Creating action plans and overseeing development strategies to ensure high-quality CRA services and achievement of departmental goals.
2. Assisting with project resourcing, updating tracking systems, and coordinating with project teams.
3. Collaborating with clinical leads and management to meet resource and site requirements.
4. Mentoring, managing, and coaching CRA staff to maintain quality standards and support their career growth.
5. Conducting site visits to assess CRA skills, address developmental needs, and resolve project issues.
6. Identifying quality risks, recommending corrective actions, and addressing performance issues.
7. Ensuring staff have necessary resources, training, and system access.
8. Monitoring and updating administrative documentation and systems.
9. Working with management to improve CRA procedures and promote efficiency.
10. Developing metrics for CRA oversight and participating in their evaluation.
11. Participating in the interview process for new CRAs, including CV reviews and interviews.
12. Conducting onboarding training for new CRA staff in collaboration with HR and training teams.
13. Representing the company professionally.
14. Managing CRA staff in alignment with company values and policies.
15. Supporting planning, work assignment, and performance feedback processes.
16. Performing additional duties as assigned by leadership.

Qualifications :

1. A degree in a scientific or healthcare discipline or equivalent experience.
2. 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 systems and medical records.
3. Strong monitoring experience in oncological clinical trials.
4. 3-5 years of direct supervisory experience managing CRAs, including developing training programs and evaluation processes.

Skills and Competencies :

1. Mastery of ICH-GCP, local regulations, SOPs, and clinical study phases.
2. High emotional intelligence and passion for people management and development.
3. Ability to develop training plans and hold personnel accountable.
4. Deep understanding of clinical research operations and problem-solving at the site level.
5. Proficiency with EMRs and EDCs.
6. Self-motivated, organized, and capable of independent and team work.
7. Excellent interpersonal, presentation, and problem-solving skills.
8. Commitment to continuous improvement and professionalism.

Additional information regarding privacy, equal opportunity employment, accommodations, and fraud prevention is provided in the original description.