Clinical Data Operations Manager

Job Title: Senior Data Operations Manager

Location: Bethesda, MD (Hybrid. 1-2 Days a week in office Minimum)

Hours: M-F 8am-5pm EST.

Pay: $86,000 - $134k,000 DOE

Type of Hire: Direct Hire

*Applicants must be US Citizen for Clearance Requirements*

About Company:

Our client is a nonprofit organization dedicated to advancing military medicine; who serves  military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, they have served as a vital link between the military medical community and its federal and private partners. The companies support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

About Role:

We are seeking a Senior Data Operations Manager, Data Coordination Center to assist the Chief of Data Operations in overseeing and ensuring accountability for all clinical data management activities within Infectious Disease Clinical Research Program's (IDRCP) Data Coordination Center (DCC). This includes, but is not limited to, the direct supervision and oversight of the DCC functional Team Leads and staff and assisting with DCC engagement with IDRCP’s Center Operations committee and Science Directorate leadership. In addition, the Senior Manager, under the direction of the Chief of Data Operations, will assist with clinical data management and data processing planning and function, including direction of human and system resources and processes. A primary objective of this position will be ensuring the delivery of high-quality data for each research protocol.

The IDCRP was founded in 2005 under an interagency agreement between the Uniformed Services University of the Health Sciences (USUHS) and the National Institute of Allergy and Infectious Diseases (NIAID) and through a cooperative agreement. IDCRP’s work is executed through a unique, adaptive, and collaborative international clinical research network. This network directly affects force readiness by advancing clinical practice and informing health policy for military personnel.

Responsibilities

• Effectively supervises the DCC:
  • Ensures effective data management operations through staff oversight and training, creating a climate of cooperation and support, and promoting connectivity among the DCC and internal and external collaborators.
  • Ensures the DCC meets operational objectives for IDCRP’s study protocols in coordination with the Chief of Data Operations, Center Operations, Science Directorate, and Principal Investigators.
  • Manages DCC functional Team Leads and staff to prioritize tasks and allocate staff to ensure delivery of expected products on an appropriate timeline within a highly dynamic environment.
• Oversees the DCC operations in support of new and ongoing clinical research protocols:
  • Manages and ensures training of DCC staff in proper data collection and management, hardware and software, and implementation.
  • Maintains external awareness of best practices within the clinical data management space.
  • Supervises DCC staff in following Good Clinical Practices and Good Clinical Data Management Practices.
  • Leads the development, maintenance, and governance of DCC standards by providing oversight and guidance on general policies, standard operating procedures, and quality assurance processes for data collection, abstraction, analysis, submission, and reporting.
  • Completes and oversees analysis of protocol documents to generate study database design specifications including CRF/eCRF design, visit schedule, edit checks, system notifications, query logic, user role setup, randomization triggers, supply triggers, and medical coding.
  • Plans, leads, and effectively supervises database setup activities, ensuring appropriate database documentation.
  • Develops data management SOPs as well as clinical trials data management best practice implementation guidelines; ensures staff training and compliance.
  • Ensures, reviews, and quality controls against associated project protocol, NIAID requirements, CRF standards templates, Good Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards.
  • Oversees the development of data quality processes to guide users through data entry and prevent erroneous data entry and values.
  • Performs database validation as well as User Acceptance Testing (UAT), and documents databases in accordance with programming standards and validation procedures.
  • Supervises setup and review of data management documentations and operational activities.
  • Develops clinical data management training and mentorship programs as well as presents at clinical data management training events and workshops.
  • Act as Subject Matter Expert (SME) of clinical data management techniques, processes, systems, and their implementation.
  • Supervises direct reports and mentors staff.
• Direct Supervisor: Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conducting employee performance evaluations, and directing work activities.

Requirements:

• US Citizenship and the ability to obtain a T1 and T3 Clearance.
• Bachelor's Degree required, Master's degree preferred.
• More than 10 years of experience required.
• Minimum of 5 years of supervisory and operational management experience required.
• Clinical/human subjects data management experience
• Expert in multi-site clinical research project/protocols with regard to data management through all phases of protocol development, execution, and close out.
• Experience with the administration and utilization of electronic data capture (EDC) systems for collection of clinical research data; REDCap experience preferred but not required.
• Possess broad technical knowledge in relevant programming languages and data systems (e.g. SAS, Oracle, SQL, PHP), as this position is responsible for the supervision of DCC staff implementing technical components required to support data acquisition, analysis, and reporting for complex projects.
• Ability to manage teams located around the continental United States and to work with Program staff and investigators located around the world.
• Proficiency effectively using collaborative software such as MS Teams in support of data operations.
• Strong clinical data management capabilities.
• Experience with EDC system administration, data collection instrument development/programming, and database management.
• Excellent communication skills.
• Experience managing data management operations and supervising data management operations staff.
• Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Preferred Experience/Qualifications:

• A certified Clinical Data Manager (CDM) certification preferred.

Work Environment

• This position will take place primarily in an office setting.

Level One Personnel is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other status protected by law.