Scorpion Therapeutics
Senior Manager, Clinical Data Management
Scorpion Therapeutics, Redwood City, California, United States, 94061
Role Summary
Senior Manager, Clinical Data Management
Responsibilities
Act as the lead data manager across one or more clinical studies.
Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
Reviews protocols for appropriate data capture including electronic (eCRF) design.
Support CRF design, review, and validation of clinical database.
Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
Generates, resolves, and tracks data queries to ensure the integrity of the clinical data.
Facilitates and participates indatacleaning activities.
Generates and/or reviews/approves study documents.
Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.
Proactively identifies potential data management issues/risks and communicates it within the study team for further action.
Qualifications
Minimum BA/BS in scientific or health-related field.
Minimum of 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
Oncology trial experience required, hematology/oncology preferred.
Possesses a comprehensive understanding of regulatory guidelines and industry standards.
Proficient with Medidata RAVE; experience working on Medidata Suite products preferred.
Familiarity with various data visualization, analytics, and reporting tools is a plus.
Excellent communication skills, strong organizational skills, and ability to work independently and effectively prioritize tasks in a fast-paced setting.
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Responsibilities
Act as the lead data manager across one or more clinical studies.
Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
Reviews protocols for appropriate data capture including electronic (eCRF) design.
Support CRF design, review, and validation of clinical database.
Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
Generates, resolves, and tracks data queries to ensure the integrity of the clinical data.
Facilitates and participates indatacleaning activities.
Generates and/or reviews/approves study documents.
Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.
Proactively identifies potential data management issues/risks and communicates it within the study team for further action.
Qualifications
Minimum BA/BS in scientific or health-related field.
Minimum of 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
Oncology trial experience required, hematology/oncology preferred.
Possesses a comprehensive understanding of regulatory guidelines and industry standards.
Proficient with Medidata RAVE; experience working on Medidata Suite products preferred.
Familiarity with various data visualization, analytics, and reporting tools is a plus.
Excellent communication skills, strong organizational skills, and ability to work independently and effectively prioritize tasks in a fast-paced setting.
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