Clinical Trial Manager

ICON; Venezia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization is seeking a Clinical Trial Manager in Venice, Italy. In this role, you will oversee the planning and execution of clinical trials, ensuring they adhere to timelines and regulatory standards. The ideal candidate will have a university degree in medicine or science, along with proven project management skills and the ability to collaborate effectively with cross-functional teams. The position offers competitive benefits focused on employee well-being and work-life balance.

Servizi

Annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme

Life assurance

Flexible country-specific benefits

Competenze

• Proven ability to drive clinical study deliverables.
• Subject matter expertise in the designated therapeutic area.
• Prior monitoring and CTM experience required.
• Ability to travel up to 20%.

Mansioni

• Plan and manage all aspects of clinical trials.
• Collaborate with cross-functional teams.
• Build and manage relationships with trial investigators.
• Ensure compliance with regulations and guidelines.

Conoscenze

Project management

Clinical study deliverables

Interpersonal skills

Detail-oriented

Problem-solving

Formazione

University degree in medicine, science, or equivalent experience

Strumenti

Veeva Vault

Microsoft Office applications

Descrizione del lavoro

We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will oversee the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.

What you will be doing

• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
• Build and manage strong relationships with trial investigators and stakeholders.
• Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
• Serve as the primary point of contact for the clinical aspects of designated projects and develop successful cross-functional relationships with internal and external stakeholders.
• Plan, schedule, and implement the clinical aspects of projects in line with contracts and budgets, including protocol implementation, amendments, deviation prevention, and IP management.
• Drive enrolment to meet contracted timelines.
• Monitor key clinical metrics such as Days on Site, Monitoring Visit Reports, Follow-up Letters, and Action Items to ensure they are met and followed-up as necessary.
• Oversee review and approval of visit reports, including site issue escalation and resolution.
• Ensure timely and accurate entry of clinical data into CTMS systems.
• Contribute to the development and maintenance of clinical project plans.
• Work on multinational studies and potentially serve as a Global CTM.
• Document clinical risks and develop mitigation strategies, including issue escalation and resolution.
• Develop and maintain operational plans for clinical deliverables such as CRF guidelines, Monitoring Plans, Recruitment Plans, and Training Plans.
• Maintain up-to-date core clinical portions of the TMF in accordance with SOPs and FMP, including QC checks.
• Complete close-out activities, including EOT notifications, payments, CTMS updates, and report finalizations.
• Lead or participate in clinical team meetings and ensure effective communication of study progress and issues.
• Implement QC activities, ensure compliance with quality measures, and monitor quality metrics.
• Maintain confidentiality of information.
• Participate in business development activities like bid defense meetings.
• May undertake individual project management tasks under supervision.

You are :

• University degree in medicine, science, or equivalent experience.
• Proven ability to drive clinical study deliverables.
• Subject matter expertise in the designated therapeutic area.
• Prior monitoring and CTM experience required.
• Ability to travel up to 20%.
• Goal-oriented, self-starter, able to work independently.
• Proactive in issue identification and resolution.
• Detail-oriented.
• Capable of managing multiple tasks and meeting deadlines.
• Proficient with Veeva Vault and Microsoft Office applications.
• Good interpersonal skills.
• Comfortable with ambiguity and acting without complete information.

What ICON can offer you :

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements.
• Health insurance options.
• Retirement planning options.
• Global Employee Assistance Programme through TELUS Health.
• Life assurance.
• Flexible country-specific benefits like childcare vouchers, gym discounts, and travel passes.

Visit our careers website to learn more about working at ICON. ICON is committed to an inclusive environment and equal opportunity employment. If you need accommodations during the application process, please inform us.

We encourage you to apply even if you don’t meet all the requirements; you might still be the right fit for this or other roles at ICON.

J-18808-Ljbffr