Clinical Data Manager
The candidate will have a scientific background (BS degree or higher) with 3-5 years of clinical data management experience in the pharmaceutical/biotechnology industry. The individual must be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. MedDRA and WHO Drug coding proficiency is preferred. Previous experience with reviewing data and database validation for EDC (DSG’s eCaselink is preferred) is required. Knowledge of CDISC/SDTM standards is also highly desired.
MAJOR RESPONSIBILITIES AND DUTIES:
This position is responsible for data management activities, including developing data management plans, validating/testing databases, defining specifications to review data (manual, automatic (EDC edit checks), and SAS validations), and reviewing/tracking clinical trial data to ensure the completeness, accuracy, and consistency of the data collected during clinical trials.
Study Specific Activities:
•Coordinate and complete data management activities to meet project timelines and communicate status to clinical project managers.
•Develop study specific data management plans and case report form (CRF) completion guidelines.
•Review and approve documents associated with data collection: CRFs, edit checks, data handling conventions, and data entry instructions.
•Review and finalize clinical study database validation plans, lead the database validation team, and ensure all documentation is completed prior to GO-LIVE.
•Complete data verification process (i.e., issue data clarification forms (DCFs) for paper CRFs or issue queries for EDC). Review completed DCFs and/or queries to ensure data discrepancies are resolved in the database.
•Prepare electronic data transfer protocols and coordinate data transfers (imports and exports) with third party vendors and consultants, and with Project Biostatisticians.
•Lead database cleaning and lock activities, coordinating data transfer reconciliation, serious adverse event reconciliation, and database audits with QA or data quality reviews with another Clinical Data Manager.
•Ensure all study specific documentation is filed appropriately in the study-specific Trial Master File.
•Manage and prioritize data management activities to meet project schedules.
•Report on required data management metrics to ensure efficient review of data.
•Develop data management resource forecasting and tracking model to assist with project planning and support.
•Optimize database development and validation processes to improve departmental efficiency.
•Train and mentor Clinical Data Associate(s) to develop clinical data review and other technical data management skills.