Hybrid Principal Clinical Data Manager

Posted last month

Apply now

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

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)
  • Collaborative and innovative team environment

Job title

Principal Clinical Data Manager

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Associate's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job