Senior Clinical Trial Manager at International AIDS Vaccine Initiative (IAVI)

• IAVI is seeking a highly motivated Senior 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 Sr. 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:

• Develop the Protocol Management Plan (PMP) and coordinate the development of operations plans for all applicable functions for inclusion in the PMP.
• Develop study timelines and ensure adherence; Escalates concerns/issues related to timelines to senior management appropriately.
• Lead clinical trial team meetings and contribute clinical updates to cross-functional project team meetings.
• Oversee the evaluation, development, set-up, training, and monitoring of investigational sites participating in epidemiology studies and clinical trials.
• With oversight from the Associate Director and/or Director, Clinical Operations, develop and control study budgets, working with other departments as appropriate, to ensure execution of studies within budget; escalate concern /issues related to budget management to senior management appropriately.
• Assist the Associate Director, and/or Director, Clinical Operations 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.
• Proactively anticipate risks, and plan for and implement risk mitigation strategies throughout the trial conduct, keeping senior management informed appropriately.
• Actively manage issues that could impact study progress, and take actions or make recommendations to solve issues to support compliance
• Coordinate and assist in developing study protocols.
• Develop Informed Consent Documents, Study Operations Manual, monitoring plan, tracking forms, and other study related documents as required.
• Lead implementation of risk-based monitoring for assigned studies.
• Review and approve monitoring visit reports submitted by CRAs for assigned studies.
• Complete monitoring oversight visits as needed to review clinical data for accuracy and completeness and resolve discrepancies in accordance with the study monitoring plan.
• Maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials.
• Mentor and train CRAs and Clinical Trial Associates, Clinical Operations Specialists and Clinical Trial Managers as needed.
• When assigned a trial with a Clinical Operations Specialist (COS), delegate clearly defined clinical trial management activities to the COS and ensure deliverables are met with appropriate timeliness and quality; mentor and provide training to the COS as needed.
• Contribute to the Clinical Development (CD) departmental Standard Operating Procedures for conduct of clinical trials based on IAVI templates as well as ensure adherence to regulations/guidelines for GCP.
• Perform other duties as assigned by the manager.

Education and Work Experience:

• Bachelor’s degree in a scientific or related field is required; an advanced degree is highly preferred.
• Minimum 7 years relevant experience in clinical trial operations, including 4 years in clinical trial management or equivalent experience at study sponsor or CRO is required.

Qualifications and Skills:

• Expert knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR and other relevant regulations as well as Declaration of Helsinki and relevant country-specific regulations is required.
• Experience in project management, including skills and the ability to deliver on assigned tasks within deadlines is required.
• Experience leading multi-disciplinary clinical trial teams, effectively to deliver clinical trials at high quality, on time and within budget is required.
• Strong interpersonal skills and ability to work effectively with outside vendors, collaborators, subordinates and functional peer groups at various management levels.
• Ability to work on problems of high complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is highly desirable.
• Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required.
• Being detail-orientated, with the ability to work independently on multiple projects/tasks with overlapping schedules and priorities is highly desirable.
• Following all company safety practices, Standard Operating Procedures (SOP’s) and policies is required.
• Excellent oral and written communication skills are required. This includes ability to conduct presentations of technical information concerning specific projects and to be an effective trainer.
• Ability to mentor other clinical operations staff is required.
• Experience working collaboratively with people of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI is required.
• Experience with electronic document management systems such as Veeva as well as electronic data capture systems is required.
• Excellent computer skills with software tools needed to fulfill the responsibilities of position is required.
• Familiarity with HIV, TB, emerging infectious diseases and/or global health and managing vaccine trials in Sub-Saharan Africa is highly desirable.