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Principal Clinical Data Manager

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Framingham, MA
$90,000 - $115,000
Job Type
Direct Hire
Aug 23, 2016
Job ID
The Principal Clinical Data Manager demonstrates quality in all actions; Responsible for managing and/or executing the design, documentation, testing, and implementation of data collection systems and processes through the lifecycle of a clinical trial.  Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
Responsibilities may include oversight and/or management of external vendors (CRO’s) for outsourced activities such as CRF development, database set-up activities, data validation process, medical coding, SAE reconciliation), training of study site personnel in CRF completion, and data clarification processes as appropriate.  Participates and may lead data management data review activities (cleaning activities including listing review, external data reconciliation and data review) and any other clinical study team data reviews required, and so ensuring completion of all activities leading to the study database lock.  An additional key responsibility will be assurance of consistency of data collection and data standards across multiple projects and systems.
Essential duties and responsibilities
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Manages all data management activities pertaining to the design, documentation, testing, and implementation of data collection systems in support of one or more clinical trial(s), which includes:
  • Assists with managing delivery of Clinical Data Management (CDM) outputs for projects through full data management process life-cycle for 2 or more projects independently.
  • Ensures that CDM activities are conducted according to applicable regulations and in a way that contributes to the objectives of each study.
  • Acts as a technical consultant ensuring appropriate development, maintenance, and use of data capture technologies for assigned projects.
  • Demonstrates strong understanding data models and supports data standardization
  • Performs and/or reviews medical coding of adverse events and medications
  • Performs data cleaning activities including listing review, external data reconciliation and data review
  • Assists with oversight of external data and facilitating data transfers to internal and external stakeholders
  • Appropriately manages projects where CDM is outsourced (CRO management)
  • Measures and reports data quality
  • Oversees development of database specifications
  • Oversees or executes database development and conducts appropriate user acceptance testing
  • Manages processing of data discrepancies
  • Oversees or executes Case Report Form and Completion Guideline development and approval
  • Communicating with external vendors to define required file format and content specifications for electronic files
  • Responsible for archival of data and CDM documentation
Required Knowledge, Skills, Abilities
  • Overall understanding of ICH, GDP, GCP and other applicable regulatory guidelines
  • Computer proficiency and knowledge of medical terminology
  • Excellent attention to detail
  • Strong understanding of project planning and management methods
  • Demonstrated ability to make timely decisions using sound judgment
  • Excellent interpersonal, communication, and organizational skills
  • Clear and concise in verbal and written communication
  • Fosters smooth flow of timely and relevant information
  • Demonstrated ability to work independently
  • Strong initiative and positive attitude
  • Ability to support and build collaborative relationships both internally and externally
  • Experience managing Data Management team
  • Oversight of CRO Data Management activities
Required Education/ Experience
  • BA or BS degree
  • 6-10 years of experience in the device, biotechnical and/or pharmaceutical industry
  • 5 years experience directly-related to the Clinical Data Management area
  • Device experience and cardiology experience highly preferred
  • Proficient in the development and use of EDC systems and reporting tools (e.g. Medidata Rave and Rave BOXI reporting environment).
Preferred Experience
  • Trained in Rave Architect Training is highly preferred
  • SAS programming knowledge is highly preferred