Clinical Program Manager at International AIDS Vaccine Initiative (IAVI)

Reports to: Associate Director, Clinical Research Management, Africa     

The Role

Position Summary:

A Clinical Program Manager (CPM) performs activities associated with implementation, managing and  monitoring clinical research studies, including Phase I-III clinical trials as well as observational and epidemiology studies. The CPM performs management of study site activities to ensure the integrity of clinical data and all study documentation in adherence to all applicable regulatory guidelines and procedural documents.  The CPM will be required to travel extensively to clinical research centers in Africa.

Key Responsibilities:

• Facilitate the evaluation, development, set-up, training, and monitoring of investigational sites participating in epidemiology studies and clinical trials
• Perform clinical trial initiation and close-out activities while adhering to all applicable regulatory and IAVI procedural documents.  Complete IAVI required report forms for all site visit activities.
• Coordinate writing and review of study protocols
• Write Study Operations Manuals and other study-specific documents to be implemented on site as required.
• Develop study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents as required
• Review and approve monitoring visit reports submitted by CRAs for assigned studies
• Complete monitoring visits as needed to review clinical data for accuracy and completeness and resolve discrepancies in accordance with the study monitoring plan
• Assure study site adherence to the protocol, GCP, procedural documents and suggest necessary action to ensure compliance and consistency
• Anticipate/identify potential problems, implement corrective actions and escalate where appropriate
• Collaborate with Manufacturing representative in planning for vaccine supply management
• Ensure proper storage, dispensation, and accountability of all investigational product(s) and trial-related material
• Work closely with monitors hired through Contract Research Organizations (CROs), ensure timely and appropriate follow-up of issues raised by monitors
• Receive and review weekly enrollment updates during site/study enrollment period and update team
• Contribute to the Medical Affairs departmental Standard Operating Procedures for conduct of clinical trials based on IAVI templates and ensures adherence to regulations/guidelines for GCP
• Conduct off-site monitoring of data captured electronically and liaise with sites and IAVI data management to resolve data queries
• Maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials
• Mentor and train CRAs as needed.
• Conduct GCP training for research staff and other key stakeholders in conjunction with other MA staff
• Participate in teleconferences, Investigator Meetings, Site Initiation Visits, Study Close-Out Visits and additional visits to sites as needed
• Liaise with research centers to assist with preparations for timely ERC and RA submissions, ensure internal IAVI review prior to submission, and track submissions and approvals
• Ensure proper internal follow-up and management of Adverse Events (AEs) and Serious Adverse Events (SAEs) per protocol as needed. Ensure SAEs, safety update reports and other new information or Sponsor reports are provided to and received by the sites for reporting as needed.
• Maintain electronic Trial Master File for assigned studies and assist with document management and archiving as needed
• Other duties as assigned

Experience and Skills:

• BS/BA in a life sciences field or professional nurse (RN) or equivalent required. Advanced degree, nursing degree or a master’s degree in public health is desirable.
• Minimum of 3-5 years experience as a CRA or equivalent clinical trial related work. A proven and successful track record in monitoring and management of investigational sites in large multi-center trials
• Experience in reviewing clinical trial data assuring accuracy, completeness and adherence to protocols and regulations/guidelines regarding good clinical practices
• Experience with HIV and/or vaccine clinical research trials, HIV related laboratory procedures and clinical safety laboratory testing is desirable.
• Strong proficiency in Good Clinical Practices (GCP), ICH guidelines and regulatory procedures with the ability to train site personnel as needed. Proven track record of meeting clinical trials milestones, timelines and working closely with clinical trial sites to ensure objectives are met.
• Self-motivated, resourceful with strong organizational skills and able to multi-task and work collaboratively and effectively in large, complex, multi-departmental, cross-functional teams. Experience working within Project Teams desirable.
• Able to take responsibility for completion of tasks with high quality according to established program timelines, identify problems and possible solutions and assess the impact on timelines
• Proven ability for effective verbal and written communication
• Excellent computer skills with working knowledge of MS Word, Excel, Outlook are required. Additional skills with MS Project desirable.
• Flexibility and willingness to travel to different research centers