Clinical Data Manager

  • location: Fort Washington, PA
  • type: Permanent
  • salary: $100,000 - $120,000 per year

job description

Clinical Data Manager

Job Title: Sr. Clinical Data Manager

Position Responsibilities

  • Participate in the review of Clinical research documents (e.g., Protocols, Case Report Forms, Reports and Statistical analysis).
  • Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
  • Develop Case Report Form (CRF), electronic and/or paper.
  • Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
  • Lead EDC database (DB) specification process
  • Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
  • Reconcile electronic data transfers from vendor to Sponsor.
  • Develop test scripts and execution logs for User Acceptance Testing (UAT).
  • Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
  • Perform training on study trial for EDC and create user guides.
  • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
  • Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
  • Coordinate the archiving of study databases and related documents.
  • Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
  • Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
  • Assist and provide input into study and project level data analysis plan.
  • Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests, project plans, and/or eCRF development activities.
Position Requirements

  • Bachelor's degree in a science related field.
  • At least 8 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
  • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Working knowledge of Clinical database applications such as EDC
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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