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
Benefits
Competitive compensation package
Comprehensive benefits
Opportunity for personal and professional growth
Flexible work arrangements (home based in Portugal, Spain, UK or hybrid in Poland, Sweden)
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