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Responsible for reviewing the data management documentation, data management plan (DMP), CRF, study database specifications, data validation plan, edit check specifications, data transfer specifications, data issue logs, data review plans and ensures all documents follow study design and regulatory requirements.
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The position acts as DM resource to the Clinical Study team and guides the team in the coordination of clinical data review, query generation / resolution and reconciliation activities.
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Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM. Requirements:Doctorate Degree OR Master's Degree and years of clinical experience ORBachelor's Degree and years of experience OR associate's degree and years of experience.
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Troubleshoot technical issues and design effective data review processes. Minimum 10 years of experience in Clinical Data Management. Manage Data Management tasks from study start-up to database lock for assigned studies.
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Responsible for overseeing creation and approval of DM study documentation by vendors/CROs (i.e. CRFs, completion guidelines, database specs, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans.
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Coordinates cross-functional data review meetings with the clinical team. Manage the collection of data issues, reporting of findings and communication of post-review status.
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Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on the data transfer specifications, and transfer data from external sources, ensuring data is received and validated for data integrity.
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Leads the development of internal Data Review Plan and coordinates cross functional team data listing review. Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC.
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Review clinical study protocols and provide comments if any. Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies related to clinical trials.
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Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
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