Responsibilities:

• Assists with plans and management of day-to-day operational aspects of one or more assigned programs/projects or tasks, including the following, as required: planning/timelines, budgeting/resourcing, and vendor management/interfacing. Identifies and proactively works to remove obstacles, mitigate risks, and escalates issues; both internally and to the client [Contracting Officer’s Representative (COR), or designee(s)], as needed.
• Responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments (if required).
• Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.
• Interfaces with client and program/project staff; ensures provision of meeting agendas and summary documentation and /or detailed information as required for internal and client meetings.
• Lead and/or actively participate in the conduct of clinical team meetings. May prepare sections for monthly, quarterly, and annual reports; and, present at internal and/or scientific meetings.
• Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and/or interacting with other Stakeholders/ Managers, as appropriate. Conduct of site visits (SAV/SQV-SIV-IMV-COV) may be required, based on specific contract needs. Travel expectations not expected to exceed 20-25% on average when needed.
• Responsible for the development and maintenance of operational plans for clinical deliverables e.g., eCRF completion guideline, Clinical Monitoring Plan (CMP), Recruitment Plan, Training Plans, etc.
• Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and applicable Plans, including involvement in archiving as necessary.
• Ensures project quality and compliance with FDA regulations and ICH (R2) guideline, and with NIH policies or other sponsors-specific requirements.
• Provided oversight and mentorship to staff in the delivery of quality work and performance, as per task order and/or project deliverables, may include line management responsibility and staff hiring. Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.
• Drives innovative project and company performance improvement solutions and sharing of best practices, including corrective and preventive (CAPA) actions, as needed.
• Contributes to Business Development and Corporate Initiatives, e.g., SOP development and proposals for government and commercial clients.
• Contribute to other reasonably related tasks, as assigned.

Requirements:

• Bachelor’s Degree in life science or another health-related field (Master’s Degree a plus).
• 5 to 7 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO) or other clinical trials environment; e.g., hands on regulatory, clinical operations (in-house CRA or study coordinator), and site monitoring experience (at least 3-4 years as a CRA/Site Monitor).
• Working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH (R2) guidelines and hands on regulatory, clinical operations, or clinical trial monitoring experience.
• Demonstrated ability to take a leadership role and drive quality progress.
• Strong presentation, problem-solving, and conflict resolution skills.
• Seasoned oral and written communication skills.
• Demonstrated task management skills, with senior team member oversight.
• Background in Infectious Disease/HIV clinical trials and/or Oncology; or experience in the conduct of Phase 1 protocols or prior work on a government contract, is a plus.

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