Clinical Operations Manager

Axle•Rockville, MD

7d•Onsite

About The Position

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.

Requirements

Bachelor's degree in a related discipline or equivalent.
Minimum of seven (7) years of experience in a related field.
Demonstrates experience with program and protocol management, and budget tracking.
Proficiency with MS Office and SharePoint.

Nice To Haves

Field of Study: Business Management and Administration

Responsibilities

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.
Assist RDB/ESTIB staff for development, collection and quality review of essential clinical studies documents and entry into DMID databases.
Track the development of monitoring plans and status of data/safety reviewers.
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.