Senior/Principal Clinical Data Manager

Description

• Review protocols for proper data capture including Case Report Form design. Able to perform a thoroughly detailed review of CRF data requirements.
• Designs CRFs and creates annotated CRF and CRF completion guidelines.
• Develop a Data Management Plan that outlines CRF flow, data queries, manual checks, and data listings needed to facilitate Data Management activities throughout a clinical study.
• Leads and coordinates the design and testing of clinical study databases to match CRFs according to company standards. Able to resolve database issues with team members
• Supervise and assist with clinical data entry as needed
• Setup databases for individual study protocols
• Develop data edit check specifications and run data listings as required
• Generate data query forms to be resolved at investigational sites and enter resolutions into database
• Perform coding of adverse events, concomitant medications and medical history
• Import electronic data into the database
• Perform database lock and freeze activities per company SOPs
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Provides guidance and monitors the progress of data management activities with CROs or other vendors
• Ability to present clinical study CRFs and CRF completion instructions at investigator meetings and other trainings as needed.
• Participate in regular team meetings and provide input when appropriate
• Provide input into the development of data management SOPs and processes
• Interact with CRAs, programmers, study managers and statisticians in creating an clinical study database, performs data quality assurance activities, and manages the resolution of data queries
• Assist in database upgrades/migrations including performing User Acceptance Tests
• Ability to write or review Data Management work instructions and SOPs
• Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
• Ability to maintain study workbooks and data management files

• BA/BS or equivalent experience, preferably in the scientific/health care field.
• At least 5 years in Data Management for the pharmaceutical/biotechnology industry. Candidates with at least 10 years of experience can be considered for the Sr. Clinical Data manager position.
• Experience with Relational databases, SQL, SAS and Clinical Data Management Systems.