The Clinical Trial Manager (CTM) plays a vital role in managing the operational aspects of clinical studies, ensuring global accountability from the Final Protocol Concept Sheet to the Clinical Study Report (CSR) and results disclosure. The CTM brings operational expertise and cross-functional management to deliver assigned trials on time, within budget, and in compliance with quality standards, SOPs, and regulatory requirements.
Reporting to the Clinical Trial Lead (CTL), the CTM may oversee a cross-functional Clinical Trial Team (CTT) for less complex trials, working alongside the Lead Trial Physician. The CTM will manage operational planning, global coordination, and execution of assigned studies, while maintaining timelines and budgets, overseeing external partners, and addressing risk management and issue resolution.
- Team Leadership: Establish and lead the CTT in collaboration with the Lead Trial Physician, coordinating with functional leaders to assign team representatives.
- Trial Execution: Ensure clinical trials comply with protocol requirements, ICH-GCP, and internal procedures. Communicate transparently and collaborate effectively with team members and external partners to achieve trial objectives.
- Operational Oversight: Oversee cross-functional planning, track study progress, and proactively manage trial deliverables and milestones.
- Vendor Management: Lead and oversee CROs and other vendors, ensuring compliance with contractual obligations.
- Risk Management: Identify and mitigate risks, collaborate on solutions, and manage contingency planning. Escalate significant issues as necessary.
- CRO and Vendor Collaboration: Participate in the evaluation, selection, and contracting of CROs and vendors, ensuring alignment with protocol requirements, budget, and timelines.
- Training and Meetings: Ensure all team members receive appropriate trial-specific training. Oversee the setup and coordination of Investigator Meetings.
- Documentation Development: Contribute to the creation of trial-related materials, including protocols, monitoring plans, and patient information documents.
- Patient-Centric Approach: Act with the goal of minimizing patient and site burden throughout the trial process.
- Feasibility Management: Oversee country and site feasibility processes, ensuring cross-functional alignment.
- Product Availability: Ensure timely availability of investigational products at sites and maintain clinical site accountability records.
- Site Oversight: Conduct site visits, review monitoring reports, and ensure data quality and compliance. Proactively address any issues that arise.
- Recruitment and Retention: Collaborate with the Site & Patient Engagement team, CROs, and other vendors to develop recruitment and retention strategies that foster positive patient experiences.
- Adverse Event Reporting: Ensure timely documentation and reporting of adverse events (AEs) and serious adverse events (SAEs), collaborating with regulatory authorities as needed.
- Trial Master File Management: Maintain and ensure the Trial Master File (TMF) is current and accurate.
- Inspection Readiness: Collaborate with Quality Assurance to ensure constant readiness for audits and inspections, providing necessary support during these processes.
- Additional Responsibilities:
- Provide feedback on the performance of CTT members and assist in onboarding new CTMs.
- Embrace innovation by identifying inefficiencies and proposing improvements.
- Share best practices and lessons learned with the team.
- Contribute to procedures, SOPs, and related documentation.
- Participate in process improvement initiatives within Trial Operations.
- Bachelor’s degree in a medical or para-medical field (e.g., Biology, Biomedical Sciences, Pharmacy).
- A minimum of 5 years of experience in Clinical Operations, including clinical trial management at the global level.
- Experience in the biotech sector is a plus.
- Background in rare diseases, autoimmune disorders, or oncology trials is highly desirable.
- Strong leadership abilities and effective interpersonal skills to foster internal and external relationships.
- Excellent organizational skills to manage multiple tasks and prioritize effectively.
- Proactive problem-solving capabilities, with a focus on identifying and mitigating risks.
- Strong written and verbal communication skills in a culturally diverse environment.
- In-depth knowledge of ICH-GCP and other relevant regulations.
- Proficiency with clinical study management tools (e.g., MS Project, CTMS, TMF).
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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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