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).

About the role

The Clinical Operations Manager provides services and deliverables through the performance of support services for NIAID's Division of Microbiology and Infectious Diseases (DMID) at the National Institutes of Health (NIH) in Rockville, MD.

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 in the 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 regularly to provide reports on the status of ongoing projects and 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 these meetings.
• 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 the 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, including 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.

Requirements

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

Benefits

• 100% Medical, Dental & Vision Coverage for Employees
• 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)

Pay

Salary Range: $140,000 USD - $148,000 USD