Description
Clinical Data Manager/Principal CDMA well established pharmaceutical firm in Palo Alto is looking to hire a Clinical Data Manager/Principal CDM. This is an excellent opportunity for a qualified candidate to work for a great company.
Clinical Data Manager/Principal CDM Duties:
- 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
- Contributes to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics
- Assist with the training of new employees and/or contractors
This company is looking to fill this position immediately. If interested please respond to this post as soon as possible.
To find out more about Real please visit www.realstaffing.com