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.
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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According to the US Bureau of Labor Statistics (BLS), employment in life, physical, and social science occupations is projected to grow 5 percent from 2019 to 2029, faster than the average for all occupations, and will result in about 68,200 new jobs. Increasing demand for expertise in the sciences, particularly in occupations involved in biomedical research, psychology, energy management, and environmental protection, is projected to result in employment growth.
According to BLS, the median annual wage for life, physical, and social science occupations was $69,760 in May 2020, which was higher than the median wage for all occupations of $41,950.
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