IAVI is seeking a highly motivated Clinical Trial Manager (CTM) who manages, oversees and executes day-to-day operational activities for the conduct of clinical trials according to ICH/GCP guidelines and relevant regulatory guidelines. The CTM will lead clinical operations of early and late phase and/or highly complex clinical trials, mentor other clinical operations staff, and lead process improvement.
Key Responsibilities
Protocol Management: Develop the Protocol Management Plan (PMP) and coordinate the development of operations plans for all applicable functions for inclusion in the PMP.
Timeline Coordination: Develop study timelines and ensure adherence; Escalate concerns/issues related to timelines to senior management appropriately.
Team Leadership: Lead clinical trial team meetings and contribute clinical updates to cross-functional project team meetings.
Site Oversight: Oversee the evaluation, development, set-up, training, and monitoring of investigational sites participating in epidemiology studies and clinical trials.
Budget Management: Develop and control study budgets, working with other departments to ensure execution of studies within budget; escalate issues related to budget management to senior management.
Vendor Selection: Assist in determining which services will be conducted by IAVI and which will be outsourced to other vendors, and assists in the identification, evaluation and selection of CROs and other vendors.
Risk Mitigation: Proactively anticipate risks, and plan for and implement risk mitigation strategies throughout the trial conduct.
Issue Management: Actively manage issues that could impact study progress, and take actions or make recommendations to solve issues to support compliance.
Documentation: Coordinate and assist in developing study protocols, Informed Consent Documents, Study Operations Manuals, monitoring plans, tracking forms, and other study-related documents.
Monitoring: Lead implementation of risk-based monitoring for assigned studies; review and approve monitoring visit reports submitted by CRAs.
Mentorship: Mentor and train CRAs, Clinical Trial Associates, Clinical Operations Specialists, and other Clinical Trial Managers as needed.
Standard Operating Procedures: Contribute to the Clinical Development (CD) departmental Standard Operating Procedures (SOPs) based on IAVI templates and ensure adherence to GCP regulations.
Qualifications and Experience
Education: Bachelor’s degree in a scientific or related field is required; an advanced degree is highly preferred.
Trial Experience: Minimum of 5 years’ experience in Trial operations and two years of trial management experience is required.
Regulatory Knowledge: Expert knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR, and other relevant regulations (Declaration of Helsinki and country-specific regulations).
Project Management: Strong project management skills with the ability to deliver on assigned tasks within deadlines.
Leadership: Experience leading multi-disciplinary clinical trial teams effectively to deliver clinical trials at high quality, on time, and within budget.
How to Apply
Interested and qualified candidates should apply via the official recruiting portal link provided in the application section.
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