Senior Data Manager
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HJF is seeking a Senior Data Manager to support the Center for Neuroscience and Regenerative Medicine in Rockville, Maryland. HJF provides scientific, technical and programmatic support services to CNRM.
This position is responsible for directing CNRM Informatics Core data management services in order to maximize the effective use of Core resources. Specific areas include: data management, implementation of the program quality management plan, supervision of data management personnel, oversight of internal data management activities and CNRM Informatics Core contracts as needed. Works on problems of moderate scope and exercises judgment within defined procedures and policies. Incumbent will supervise data management team.
ESSENTIAL JOB DUTIES:
Provide technical oversight of service providers performing core data management functions including CRF/ edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures. Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards. Lead contact for ongoing communication with Core Leadership to include the Core Principal Investigators, Core Statistician, and Senior Program Manager regarding ongoing projects and deliverables. Serves as point of contact for CNRM Principal Investigators interested in working with the Informatics Core and management of associated requests and other CNRM Cores for data related requests. May assist in regulatory submissions as needed. Serve as mentor and supervisor for junior data management staff. Develops internal SOPs and training. Assists with the preparation of requests for contract actions and proposals as needed. Assists with the preparation of annual report and budget as needed. Performs other duties as needed.
Required Knowledge, Skills, and Abilities:
Knowledge of clinical research operations and data management, familiar with GCP and FDA regulations and the related management of clinical studies; ability to work completely independently; ability to use sound judgement in solving problems; ability to coordinate many projects at the same time; excellent communication and interpersonal skills; supervisory/management experience.
Minimum Education/Training Requirements: Bachelor's degree
Minimum Experience: 4 to 6 years related experience in data management in a clinical research setting; supervisory experience of data management teams preferred.
Supervisory Responsibilities/Controls: Supervises support staff
Work Environment: office setting
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.