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Job Title: Associate Director, Clinical Operations
Location: New York, New York
Responsibilities overseeing headquarter clinical operations
? Work closely with Senior Director, Global Clinical Operations and Chief Medical Officer to ensure staffing needs are identified, FTEs requested and approved as needed and personnel hired. Lead hiring process for headquarters clinical operations staff.
? Assign headquarters clinical operations personnel to projects with input from Senior Director, Global Clinical Operations and Chief Medical Officer, Clinical Development.
? Operational lead for HQ-managed studies (usually domestic trials but could be international), participating as member of project teams and supervising clinical operations personnel.
? Act as back up when a Clinical Operations team member is temporarily unable to fulfill role (e.g. leave, illness, or pregnancy).
? Provide oversight of Clinical Operations team in the preparation for and management of assigned clinical studies.
? Work closely with the study teams to ensure protocols and study related activities are conducted according to program priorities, timelines and in compliance with protocol and ICH GCP guidelines.
? Review regularly updated reports from Clinical Operations personnel, sites, and/or CROs regarding study progress including recruitment and trial conduct. Work with team members to identify site-related problems and propose resolutions as needed.
? Work on budgets and contracts as requested by the Senior Director, Global Clinical Operations
? Ensure clinical operations staff are up to date on required trainings, including identification of changes in US regulations and best practices and arranging for trainings of ops staff as needed
? Other duties as assigned.
Responsibilities as Clinical Operations Lead assigned to a particular study
? Lead the evaluation, development, set-up, training, and monitoring of investigational sites participating in clinical research studies and clinical trials.
? Assume a leadership role in planning the implementation and management of assigned clinical studies including but not limited to: preparation and review of protocol, informed consent form documents, questionnaires, training manuals, Study Operations Manuals, project contact lists, laboratory, data collection procedures, monitoring plans, tracking regulatory/ethics submissions and approvals.
? Lead coordination and review of study specific SOPs to be implemented on site providing knowledge and expertise as required.
? Assist with regulatory submission process as required including preparing and reviewing clinical documents.
? Work closely with and oversee site staff and regional IAVI representative to ensure protocols and study related activities are conducted according to program timelines and in compliance with protocol and ICH GCP guidelines.
? Organize and conduct teleconferences, investigator meetings, site initiation visits, monitoring visits, study close-out visits and additional visits to sites as needed.
? Ensure efficient coordination of clinical trial operations including co-monitoring at investigational sites assuring adherence to the protocol, GCPs, SOPs and taking necessary actions to ensure compliance.
? Ensure proper reporting, follow-up internally and assist in management of AEs/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 to IRBs, as needed.
? Prepare updates and reports regarding study progress including recruitment, trial conduct and, if needed, identifying site-related problems and proposed resolutions.
? Manage and maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials including providing global updates to the team regarding study timelines and status of project.
? Contribute to and prepare project plans including timelines, related to clinical, laboratory and data management operations, and preparation and monitoring of budgets.
? Create and update Clinical Development departmental clinical trial protocols and standard operating procedures for conduct of clinical trials based on IAVI templates and ensure adherence to regulations/guidelines for good clinical practices.
? Coordinate and assist in collection of essential documents and all aspects of documentation control and archiving to ensure a complete master file per good clinical practices.
? Liaise with Core Lab, Data Coordination Center and R&D Manufacturing Staff in planning for supplies for the study including preparation of study materials according to randomization schema, preparation of vaccine materials.
? Manage CRAs/monitors hired through Contract Research Organizations, including training on study procedures, confirm site visit schedule, review and approve site visit reports, ensure timely and appropriate follow-up of issues raised by monitors. Ensure monitors operate to highest quality standards and if necessary address any issues directly with CRO to resolve issues.
? Pro-active identification and analysis of clinical trial management and execution issues with proposals on how to resolve problems. Assume leadership role to obtain internal consensus on solutions through the appropriate internal channels at IAVI.
? Develop and maintain liaisons with the IAVI Field Team to ensure proper and timely submissions to ERCs, review and assist in preparation of appropriate responses for re-submission if necessary. Ensure IAVI reviews and approves all documents prior to submission and implementation at the site.
? Provide quarterly updates on progress of activities which impact project budget.
? Other duties as assigned.
? Undergraduate degree in scientific field or equivalent
? Advanced degree, nursing degree or a master's degree in public health
? 10 years of clinical research experience with a proven and successful track record in planning and implementing all aspects of clinical programs
? Supervisory and management experience of clinical operations staff
? Experience in reviewing clinical trial data assuring data integrity, and adherence to protocols and regulations/guidelines regarding Good Clinical Practices
? Creation and management of departmental budgets, statements of work, and contracts
? Experience working with Contract Research Organizations (CROs) providing monitoring or other clinical services
? Experience with HIV and/or vaccine clinical trials
? Clinical research in resource-limited settings, capacity building
? Strong clinical project management skills
? Proven track record of meeting organizational milestones, timelines, and working closely with teams to ensure clinical program objectives are met
? Ability to work with complex governance structures and manage large numbers of stakeholders
? Ability to work well in an international, multi-cultural setting
? Proficient in MS Outlook, Word, Excel, PowerPoint, Project, Electronic Data Capture and eTMF platforms ?
? Strong proficiency in Good Clinical Practices (GCP), ICH guidelines and regulatory procedures with ability to train IAVI staff or site personnel
? HIV, tuberculosis, emerging infectious diseases, global public health
? Community engagement and Good Participatory Practices
? Some domestic and international travel required, approximately 15%
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