Clinical Data Manager

Benefits

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Mental health support

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Schedule

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Weekend work

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Application

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About this role

Clinical Data Manager Burlington, MA Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You'll Do: We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role in ensuring the integrity, accuracy, and completeness of clinical trial data, contributing to the successful development and regulatory approval of our products. Responsibilities : - Manage and lead all aspects of clinical trial data management activities from study start-up to database lock. - Develop and implement data management plans, data validation plans, edit check plans and data entry guidelines in compliance with regulatory standards and company SOPs. - Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure data quality and integrity throughout the trial lifecycle. - Oversee Medidata Rave electronic data capture (EDC) system setup, configuration, user management, coding and data extracts. - Perform data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure timely database lock. - Conduct periodic data reviews and generate weekly data quality metrics to identify trends and outliers. - Identify Protocol Deviations - Produce medical monitor, coding listings and ad hoc listings for team review (Jreview, SAS, Business Objects). - Participate in the

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