Clinical Trial Manager

ICON; Terni; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization is seeking a Clinical Trial Manager to oversee the planning and execution of clinical trials. This role involves collaborating with cross-functional teams and ensuring compliance with regulations. Ideal candidates have a degree in medicine or science, demonstrable clinical study deliverables, and essential interpersonal skills. The position includes various benefits and competitive salary.

Servizi

Various annual leave entitlements

Health insurance options

Retirement planning options

Flexible optional benefits such as childcare vouchers

Gym memberships

Competenze

• Proven ability to drive clinical study deliverables.
• Previous monitoring experience and experience as a CTM.
• Willingness to travel up to 20%.

Mansioni

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

Conoscenze

Proven ability to drive clinical study deliverables

Detail-oriented with strong organizational skills

Good interpersonal skills

Ability to manage multiple tasks and meet deadlines

Subject matter expertise in the designated therapeutic area

Formazione

University degree in medicine or science

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 be responsible for overseeing 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

1. Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
2. Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
3. Build and manage strong relationships with trial investigators and stakeholders.
4. Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
5. Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
6. 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.
7. Plan, schedule, and implement the clinical aspects of projects in line with contracts and budgets, including protocol implementation, amendments, deviation prevention, and IP management.
8. Drive enrolment as per contracted timelines.
9. Monitor key clinical metrics such as Days on Site, Monitoring Visit Report timelines, Action Items, and other quality metrics, ensuring they are met and followed-up.
10. Oversee review and approval of visit reports, manage site issues, and escalate as necessary.
11. Ensure timely and accurate entry of clinical data into CTMS systems.
12. Contribute to the development and maintenance of clinical project plans.
13. Work on multinational studies and potentially serve as a Global CTM if appropriate.
14. Document clinical risks and develop mitigation strategies and action plans.
15. Maintain operational plans for clinical deliverables such as CRF completion, Monitoring Plan, Recruitment Plan, and Training Plan.
16. Ensure the clinical portions of the Trial Master File are up-to-date and properly archived.
17. Complete all close-out activities, including notifications, payments, and report finalizations.
18. Lead or participate in clinical team meetings and ensure effective communication of study progress and issues.
19. Implement quality control activities and monitor quality metrics.
20. Maintain confidentiality of information.
21. Participate in business development activities such as bid defense meetings.
22. Support the Line Manager with individual project management tasks as needed.

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.
• Previous monitoring experience and experience as a CTM.
• Willingness to travel up to 20%.
• Goal-oriented, self-starter capable of working independently.
• Proactive in issue identification and resolution.
• Detail-oriented with strong organizational skills.
• Capable of managing multiple tasks and meeting deadlines.
• Proficient with Veeva Vault and Microsoft Office applications.
• Good interpersonal skills and ability to work with ambiguity.

What ICON can offer you :

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits, including:

• Various annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible optional benefits such as childcare vouchers, gym memberships, and more

Visit our careers website to learn more about working at ICON. We are committed to an inclusive and accessible environment, providing equal opportunity employment and reasonable accommodations for applicants with disabilities.