Clinical Operations Manager

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is seeking a Clinical Operations Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Allergy and Infectious Diseases (NIAID) located in Rockville, MD. Benefits We Offer: Paid Time Off and Paid Holidays 401K match up to 5% Educational Benefits for Career Growth Employee Referral Bonus Flexible Spending Accounts: Healthcare (FSA) Parking Reimbursement Account (PRK) Dependent Care Assistant Program (DCAP) Transportation Reimbursement Account (TRN) Position Information The Clinical Operations Manager provides services and deliverables through the performance of support services for NIAID's Division of Microbiology and Infectious Diseases (DMID). This role requires a Bachelor's degree in a related discipline (or equivalent) and a minimum of seven years of experience in a related field, along with demonstrated experience in program and protocol management and budget tracking, and proficiency with MS Office and SharePoint. Additional Qualifications Certifications & Licenses Bachelor's degree in a related discipline or equivalent. Minimum of seven (7) years of experience in a related field. Field of Study Business Management and Administration Software MS Office SharePoint Skills Demonstrates experience with program and protocol management, and budget tracking. Work product and documents related to coordinating with staff to develop a system of standardized procedures for organizing clinical studies/trials logistical functions in accordance with DMID procedures. — Ad-Hoc Work products and documents related to assisting staff for development, collection and quality control of essential clinical studies documents and entry into databases. — Ad-Hoc Work products and documents related to tracking the development of monitoring plans and status of data/safety reviewers. — Ad-Hoc Work products and documents related to coordinating meetings and preparing minutes. — Ad-Hoc Work products and documents related to inventory, organizing, and filing all low resource tiered clinical study documents. — Ad-Hoc Work products and documents related to coordinating 10-day pre-Council application reviews with program staff to ensure they are appropriately assigned. — Ad-Hoc Statement of Work Details Coordinate with RDB and ESTIB staff to develop a system of standardized procedures for organizing clinical studies/trials logistical functions in accordance with DMID procedures. — 1 Assist RDB/ESTIB staff for development, collection and quality review of essential clinical studies documents and entry into DMID databases. — 2 Track the development of monitoring plans and status of data/safety reviewers. — 3 Meet with program staff on a regular basis to provide reports on the status of on-going projects and to receive new assignments. Assist on a variety of special, one-time projects that require immediate action. Plan and coordinate meetings with program staff and other attendees as requested. Take and prepare minutes from meetings with program staff and other attendees. Assist with clinical project management for ESTIB. Inventory, review, organize and file all low resource tiered clinical study documents. Work with funded investigators to ensure that all clinical documents are received as per DMID policy. Coordinate 10-day pre-Council application reviews with program staff to ensure they are appropriately assigned. Ensure that all gender and minority coding for clinical research projects are submitted and entered in appropriate databases on time. Serve as the point of contact and/or work with point of contact for selected RDB agreements, including Non-Clinical Evaluation Agreements (NCEAs), Material Transfer Agreements (MTAs), and Clinical Trial Agreements (CTAs). Assist in keeping the MIS database up to date, which includes reviewing content, uploading requests for services and study results, and working with requestors. Create and/or assist in the management of RDB and ESTIB SharePoint sites. Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed. The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate. Accessibility: If you need an accommodation as part of the employment process please contact: View email address on click.appcast.io This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location. 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