Sponsor Dedicated Local Clinical Trial Manager II - Home based ITA

Syneos Health, Inc.; Monza; Remoto; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company seeks a Sponsor Dedicated Local Clinical Trial Manager II for a home-based position in Italy. This role involves managing clinical trial site oversight, ensuring compliance and safety while collaborating with cross-functional teams. Candidates should possess strong leadership and communication skills and an understanding of clinical trial regulations.

Servizi

Career progression opportunities

Supportive management and training

Diversity and inclusion initiatives

Competenze

• Previous experience as a Local CTM required.
• Experience in an international environment preferred.
• Willingness to travel approximately 20%.

Mansioni

• Manage site oversight, focusing on patient safety and data integrity.
• Oversee site interactions from activation through closeout.
• Coordinate with other functional leaders to meet study milestones.

Conoscenze

Leadership

Conflict Resolution

Problem Solving

Communication

Formazione

Bachelor’s degree or RN in a related field

Descrizione del lavoro

Sponsor Dedicated Local Clinical Trial Manager II - Home based ITA

Updated : December 23, 2024

Location : Italy-Europe - ITA-Home-Based

Job ID : 24006899

Sponsor Dedicated Local Clinical Trial Manager II - Home based ITA

Preferred location : Milan area

Previous experience as a Local CTM is required. Experience in Neurology, rare diseases, or immuno-inflammation diseases is highly preferred.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers on the customer and patient. We aim to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.

Why Syneos Health

• We develop our people through career progression, supportive management, training, peer recognition, and rewards.
• We are committed to our Total Self culture—where you can be authentic. We care for our people and foster diversity of thoughts, backgrounds, and cultures to create an inclusive environment.

Job responsibilities

• Manage site oversight, clinical monitoring, and central monitoring focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity.
• Oversee site interactions from activation through closeout, including patient recruitment and investigator payments.
• Identify risks related to data, processes, and protocol execution, and develop mitigation strategies.
• Review study scope, budget, and protocol to ensure team awareness of obligations.
• Use experience and data to identify risks to trial management deliverables.
• Escalate risks to the project manager and propose solutions.
• Participate in key meetings and serve as an escalation point for investigator communications.
• Coordinate with other functional leaders to meet study milestones.
• Develop and maintain clinical study tools, templates, and systems.
• Train the study team on protocol specifics, data collection, and systems.
• Manage resource allocation and oversee quality of monitoring activities.
• Review dashboards and documentation to ensure compliance and quality.
• Interact with clients and internal teams regarding monitoring activities.
• Oversee team performance and provide feedback.
• May be assigned to larger or complex trials.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent experience.
• Leadership experience in project milestones.
• Experience working in an international environment.
• Expertise in site management and monitoring.
• Preferred risk-based monitoring experience.
• Understanding of clinical trial financial principles and budgets.
• Knowledge of GCP/ICH and regulations.
• Good computer skills and communication abilities.
• Strong conflict resolution and problem-solving skills.
• Willingness to travel approximately 20%.

Get to know Syneos Health

We have worked with 94% of FDA-approved drugs, 95% of EMA products, across numerous studies and sites.

Take initiative and challenge the status quo with us in a dynamic environment.

Additional Information :

Tasks and responsibilities are not exhaustive and may change at the company's discretion.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration without discrimination based on race, color, religion, sex, gender identity, sexual orientation, veteran status, disability, or other protected status.