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The Data Manager plays a broad role in interfacing with statisticians, clinical affairs representatives, and external partners and vendors to design, configure, and test the clinical database systems.
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I am working closely and exclusively with a specialist Biotech who will be looking to hire a Manager, Clinical Data Management soon. Manager, Clinical Data Management. - EDC experience - Database Builds / Study Start up / DB Locks.
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Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. The Senior Clinical Data Manager (Sr. CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock.
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Robust experience with core data management activities, EDC (eg, Medidata Rave) and use of Data Review tools. 5+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock.
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This includes Source Data Validation (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) with the Electronic Trial Master File (eTMF), ensure proper documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.
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Verify that trial data entered in the EDC is consistent with patient clinical notes and other source documentation (SDV). Monitor clinical trial progress, in conjunction with the AFT In-House Clinical Research Associate (IHCRA), through a combination of remote data review and remote/on-site monitoring visits.
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The Clinical Research Monitor works in partnership with the AFT Project Manager and individual study teams to complete all site monitoring activities across assigned AFT projects and ensures all participating sites are compliant with Good Clinical Practice (GCP), SOPs, policies, and regulatory requirements throughout the life of assigned clinical trials.
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Confirm the collection of laboratory samples as specified in the protocol and the resulting lab data when central or correlative laboratories are used. In conjunction with the Project Manager (PM) and Quality Management and Compliance (QMC) team, develop the scope of work for clinical monitoring and/or monitoring services, and associated study plans, e.g., clinical monitoring plan.
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Solid understanding of the drug development process, including Good Clinical Practice (GCP) and FDA Code of Federal Regulations. The Clinical Research Monitor will work under the Executive Director of Clinical Trial Operations and the Associate Director of Clinical Trial Operations to oversee activity at Alliance for Clinical Trials in Oncology sites participating in Alliance Foundation Trials (AFT) clinical trials.
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Perform remote and on-site monitoring & oversight activities in accordance with protocol, GCP/ICH Guidelines, and AFT SOPs. Excellent organizational, leadership, and problem-solving skills. Manage on-site medication accountability and inventory throughout clinical study.
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The Clinical Research Monitor will be responsible for monitoring activities across multiple protocols. Support the study specific operations team with communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
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Ability to travel to sites when needed for on-site monitoring. Match 3% of a Simple IRA. Provide recommendations and guidance to study specific operations teams and assist in audit readiness and preparation.
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In conjunction with the AFT IHCRA, collect, review, and monitor required regulatory documentation for study maintenance and study close-out. 100% Medical Option, Dental & Vision for employee, with 50% spouse and children - begins on the 1st day of employment.
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Builds positive relationships with principal investigators and site personnel. Actively participate with study team to stay current with study needs, communicating as needed with sites within defined timelines.
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This position is responsible for completing clinical monitoring activities at participating sites. Ensure compliance with regulations, guidelines, and policies for studies implemented at sites. In consultation with PM and QMC, develop and implement effective corrective and preventive action plans for all quality issues identified at assigned sites.
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