Edgewise Therapeutics · 3 days ago

Manager, Data Management

Massachusetts, United States

Full-time

Onsite

Senior Level

$125K/yr - $185K/yr

5+ years exp

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Responsibilities

Manage the performance of Contract Research Organizations (CRO) responsible for data management activities

Responsible for overseeing all DM activities from start-up, conduct, and closeout including CRF and EDC development

Lead/drive project deliverables and timelines

Review and approve clinical trial documentation, including timelines

Perform data cleaning and external vendor data reconciliation

Collaborate with Biostatisticians, Statistical Programmers, Medical Monitors and Clinical Operation Trial Lead, Pharmacovigilance, Regulatory Affairs, and other departments on clinical trials

Participate/lead in data management and cross-functional project clinical trial meetings

Develop and communicate metrics, to internal and external teams to ensure achievements are met

Perform other duties as needed to ensure data quality

Qualification

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Clinical Data CollectionData ManagementEDC SystemsICH GCPCDASHSDTMRegulatory Requirements21 CFR Part 11Lead/Program Data ManagerWritten/Oral CommunicationGrammatical/Technical WritingInterpersonalCommunicationSelf-MotivationLeadershipOrganizationalTime ManagementSense of UrgencyAnalyticalProblem-SolvingProject Management

Required

B.S. in a scientific field with a minimum of 5 years leading data management activities. CRO experience required pharma/biotech experience a plus

Proficient in clinical data collection, cleaning, and analysis for clinical trials; rare disease / neuromuscular and / or pediatrics experience is preferred

Experience working in an outsourced Data Management model

Experience with EDC systems is required

Solid understanding of ICH GCP as well as general knowledge of industry practices and standards (CDASH, SDTM)

Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11