Job Description

• Under the direction of the applicable management, the Clinical Data Manager (CDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
• Primary activities include but are not limited to Receives the study related paper documents (i.e. patient diary, adjudication, etc.) from sites or other functional areas, registers them into a work management tool and transfers to data enterer for processing.
• Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.
• Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM Runs data integrity check reports in accordance with data review plans and relevant SOPs.
• Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
• Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM.
• Escalates overdue items, including but not limited to outstanding questions and missing visits.
• Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock.
• Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation.
• Maintains compliance with standard key performance indicators according to process expectations at the protocol level.
• Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed.
• Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.

• A bachelor's degree in a related field and at least 3 years of experience in clinical data management are required.
• Proven expertise with electronic data capture (EDC) systems, especially Oracle Inform.
• Fluent oral and written English skills.
• Excellent organizational and time management skills.
• Good sense and awareness of regulations and policies.
• Good communication skills with the ability to communicate with both the technical and business areas.

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