Sr. Clinical Data Manager - Katalyst Healthcares & Life Sciences
San Diego, CA 92101
About the Job
Responsibilities:
- 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 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.
- Bachelor's degree in a scientific discipline, at least 3 years of clinical data management experience in the pharmaceutical/biotechnology industry.
- More experience will be required for a senior level CDM candidate.
- You 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.
- We prefer you to have MedDRA and WHO Drug coding proficiency.
Source : Katalyst Healthcares & Life Sciences