Senior Quality Analyst, Translational Research
Digital Infuzion
Principal Clinical Data Manager
TFS HealthScience
full-time
Posted on:
Origin: • 🇵🇹 Portugal
Visit company websiteJob Level
Lead
About the role
- Responsible for Clinical Data Management activities for assigned studies
- Mentor Clinical Data Managers and Senior Clinical Data Managers on specific Data Management topics
- Act as Lead Clinical Data Manager and Project Lead for Biometric-only projects
- Coordinate work of Clinical Data Management staff assigned to projects
- Plan client deliverables and manage project budgets (incl. PFU/revenue files)
- Prepare and distribute periodic project progress reports and oversee client correspondence
- Coordinate receipt and processing of project information (coding dictionaries, format libraries, database specs)
- Direct and oversee project-specific initiation, orientation, and kick-off meetings
- Review study protocol and develop or review CRFs
- Develop database, define and program edit checks, and prepare related DM documentation
- Develop Data Management Plan, Data Management Report, and Data Validation Plan
- Develop Data Entry Instructions/eCRF completion guidelines and coordinate validation of database and trial settings
- Perform CRF handling, data cleaning, and query handling
- Train and support Clinical Data Associates, Clinical Data Managers, CRAs, and study teams
- Ensure completion of Quality Control tasks and database closure, and file/archive essential documents
- Provide metrics and status updates to senior management and sponsors
- Coordinate SDTM mapping with senior programmer when needed
- Perform system validation, create test scripts, and perform UAT of ePROs
- Contribute to process improvements and provide input into proposals and Bid Defense meetings
Requirements
- Bachelor’s Degree, preferably in life science or nursing, Statistics or Computer Science or equivalent education or equivalent lower education e.g. Associate Degree
- Minimum of 8 years of relevant data management experience, including 5 years as Senior Clinical Data Manager
- Familiarity with medical terminology
- Proven data management skills
- Ability to handle multiple tasks to meet deadlines
- Proven leadership skills
- Excellent English verbal and communication skills
- Ability to deal effectively with sponsors and internal customers
- Ability and willingness to travel on occasion
- Experience with database development, edit checks, data validation, CRF development and SDTM mapping
- Experience with system validation, creating test scripts, and performing UAT of ePROs
