Overview
The Clinical Trial Lead (CTL) serves as a cross-functional leader with global responsibility for all operational aspects of clinical studies, ranging from the Final Protocol Concept Sheet to the Clinical Study Report (CSR) and results disclosure. The CTL provides essential operational expertise and strategic insights, ensuring that trials are executed within established quality standards, timelines, and budgets while complying with relevant SOPs and regulatory requirements.
As the Clinical Trial Team (CTT) Lead, the CTL will collaborate with the Lead Trial Physician. In some cases, the CTL may manage a specific subset of clinical trial responsibilities under the supervision of another CTL. This role involves driving operational planning, global coordination, and implementation of assigned studies, as well as defining the global operational strategy, maintaining timelines and budgets, overseeing external partners, and facilitating risk management and issue resolution. The CTL acts as the "Operational Voice" for assigned studies, both internally and externally.
Responsibilities
- Team Leadership: Establish and lead the CTT in partnership with the Lead Trial Physician, coordinating with functional leaders to assign representatives.
- Trial Execution: Ensure clinical trials are conducted per protocol requirements, ICH-GCP, and internal procedures. Set clear expectations and motivate team members and external partners to meet objectives.
- Independent Management: Operate with minimal supervision while ensuring effective communication and task division within the team.
- Accountability: Deliver global trials on time and within budget, tracking progress and proactively managing deliverables.
- Vendor Oversight: Guide and oversee CROs and other vendors to ensure compliance with contractual obligations.
- Risk Management: Identify potential risks, propose solutions, and lead contingency planning efforts. Escalate significant issues as needed.
- Collaboration: Work with Global Sourcing & Alliance Management (GloSAM) on the selection and contracting of CROs and vendors, ensuring alignment with study requirements and budget.
- Training Oversight: Ensure that all team members, including CROs and vendors, receive appropriate trial-specific training.
- Documentation: Contribute to the development of trial-related materials, ensuring they meet protocol and regulatory standards.
- Patient & Site Focus: Strive to reduce patient and site burden throughout the trial process.
- Feasibility Oversight: Manage the feasibility process and ensure alignment on the regional footprint.
- Monitoring Strategy: Develop and implement a site monitoring strategy, conducting oversight visits and reviewing data quality.
- Sponsor of Choice: Position our organization as the Sponsor of Choice for clinical trial participation by fostering supportive relationships with sites and enhancing recruitment strategies.
- Adverse Event Reporting: Ensure timely documentation and reporting of adverse events to regulatory authorities.
- Inspection Readiness: Maintain the Trial Master File (TMF) and ensure readiness for audits and inspections.
- Additional Responsibilities:
- Act as a backup to the Lead when necessary.
- Provide feedback on team performance and assist in onboarding new team members.
- Promote innovation by identifying inefficiencies and proposing improvements.
- Share best practices across trial teams and contribute to procedural improvements.
Qualifications
- Bachelor’s degree in a medical or para-medical field (e.g., Biology, Biomedical Sciences, Pharmacy).
- At least 8 years of global clinical trial management experience, including oversight of CROs and vendors.
- Experience in biotech is a plus, with a background in rare diseases, autoimmune, or oncology trials being highly desirable.
- Strong leadership and communication skills, with the ability to build effective relationships.
- Excellent organizational skills to manage multiple tasks and prioritize effectively.
- Proactive problem-solving abilities with a holistic view while managing details.
- Excellent written and verbal communication skills in a culturally diverse environment.
- Knowledge of ICH-GCP and relevant regulations for successful trial execution.
- Experience with clinical study management tools (e.g., MS Project, CTMS, TMF).
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