Data Manager II, Lombardi Comprehensive Care Center Georgetown University Medical Center
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Data Manager II, Lombardi Comprehensive Care Center - Georgetown University Medical Center
The Lombardi Comprehensive Care Center (LCCC), part of Georgetown University Medical Center, seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community guided by the principle of cura personalis, care for the whole person. Georgetown Lombardi is the research engine driving clinical cancer research at MedStar Health in the DC Metro area and northern New Jersey.
The Data Manager II manages the data from numerous clinical trials of varying complexity and stages and ensures the seamless transmission of data between clinical site and trial sponsor. Reporting to the Senior Data Manager, the Data Manager II has duties that include but are not limited to:
Works collaboratively with clinical trial stakeholders and internal study teams (Physicians, Regulatory Coordinators, Study Coordinators & Nursing staff, Research Laboratory Technicians, and Research Pharmacy team).
Accurately captures data in electronic or paper Case Report Forms (eCRFs/CRFs), adhering to contractual timelines and site Standard Operating Procedures (SOPs).
Ensures query resolution with proper physician and clinical study team oversight within site-specific time requirements.
Uploads radiological images into sponsor-provided imaging platforms according to each study protocol.
Resolves imaging-related queries with the assistance of clinical study team.
Collects and organizes source documents in electronic and paper format according to site policies.
Schedules sponsor monitoring and study close-out visits.
Participate sin data preparation for audits and QA review.
Communicates appropriately with pharmaceutical sponsors, auditors, study monitors, physicians and study coordinators.
Collaborates closely with physicians and study coordinators to maintain protocol integrity.
Assists with training of incoming Data Managers in data capture, query resolution, and protocol compliance.
Participates in disease team meetings, site initiation visits, audit meetings, and other study related meetings.
Performs all duties in accordance with all applicable laws and regulations. Adheres to Georgetown University Medical Center's philosophies, policies and SOPs.
Works in compliance with Human Subject Protection regulations, patient confidentiality and HIPAA requirements, and Good Clinical Practice.
Bachelor's degree in a science-related field and 2 years of related experience in clinical research orAdvanced degree in a science- related field and 1 year of related experience in clinical research
Ability to work independently and function within a team
Strong prioritization skills
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