Clinical Data Manager

This position is important to the overall operation of Promedica International.

This position reports to the Director, Clinical Services and Data Management. This position is responsible for study data.

This position may involve up to 10% of travel and requires a person who works effectively with clinicians, allied healthcare personnel, clients, vendors, and Promedica International staff by:

    • Sharing ideas in a constructive and positive manner

    • Listening to and objectively considering ideas and suggestions from others

    • Keeping commitments

    • Keeping others informed of work progress, timetables and issues

    • Addressing problems/issues constructively to find mutually acceptable solutions

    • Addressing others by name, title or other respectful identifier

  • Respecting the diversity of our work force in actions, words, and deeds


Duties of this position may be described in the following functions below.  This description is representative, but not all-inclusive, based on the company’s growth.



Project and General Management/Administration

  • Interfaces with clinical Project Manager(s) and statistician(s) to establish project data management plans and requirements, and database implementation schedules and other key study documents
  • Interfaces with IT Manager, Project Manager, and Software Developer to review project database implementation schedules, database utilization training, and database utilization efficiency
  •  Participates in the department project clinical data system design, utilization, and maintenance to maintain conformance with FDA guidelines for clinical data management
  • Review protocols for CRF design and creation and develop electronic CRFs for use in clinical data management systems
  • Develop and maintain data management documentation including: Data Management Plan, Database Development Specifications with Edit Check Specifications, Data Review Guidelines, and other Data Management Specific documents
  • Create and develop database specification documentation for database programming according to CRF 
  • Collaborate with biostatisticians in the creation of analysis datasets
  • Program and develop database in accordance with database specification and CRF documentation
  • Modify database to accommodate any requested database updates or modifications
  • Program and generate reports within database as requested by sponsor and/or project team
  • Create test data and perform user acceptance testing on new databases
  • Complete ongoing data review activities for assigned study and provided feedback to study teams
  • Coordinate with Coder or complete coding activities throughout the study
  • Coordinate with external vendors as needed for assigned study
  • Perform database quality assurance audits and database locks
  • Establishes and maintains department Standard Operating Procedures for data management activities.  Works with Quality Systems Manager and/or Administrator to revise, develop, or implement new procedures as required
  • Provides recommendations for improvement of project or divisional efficiencies based on work experience and observations
  • Participates in project review meetings as requested
  • Participates in business development proposal team and presentations as needed
  • Participates in budget maintenance for project data management-related activities

Experience/Skills Recommended for Position:

  • Proficiency in Data Management Plan development and maintenance
  • Experience with study start up tasks, CRF design, database development, edit check creation, eCRF completion guidelines, validation and user acceptance testing
  • ePRO experience
  • Database build experience, including experience with programming and database set up within Medrio and other EDC systems 
  • Thorough understanding of FDA, ICH and GCP regulations and guidelines regarding management of data for clinical studies
  • Familiarity with current data standards (e.g., XML/CDISC) and database administration
  • Proficiency in EDC systems (including Medrio and Medidata Rave) with database development, query management, reports generation and associated database specification documentation
  • Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable
  • Understanding of coding process and dictionaries
  • SAE Reconciliation and external data reconciliation experience
  • Strong communication skills as demonstrated via telephone interactions, personal presentations, and general written correspondence.
  • Well-organized, with strong attention to detail, documentation, and follow-through.  Ability to work on multiple tasks simultaneously.
  • Leadership skills, and ability to work effectively within a team configuration 
  • Willingness to both lead studies as data manager and complete ongoing data management review from start up through database lock for assigned studies 
  • Pharma and medical device experience preferred
  • Ophthalmology experience
  • 5+ years experience in data management
  • BS or BA degree