Position Overview:

The Clinical Data Manager will be responsible for the development, validation and maintenance of Clinical systems used to collect and archive Clinical Data and Records.

Job Description

• Design and maintain electronic clinical research management databases. Experience in IBM Clinical Development or equivalent clinical electronic data capture systems is highly desirable.
  
• Maintenance of data management documentation and archiving clinical trial data and study documentation.
  
• Design of case report forms and database validation checks based on an understanding of the therapeutic area of interest.
  
• Validation of electronically captured data, querying both missing data and data points failing range checks and/or logical checks.
  
• Design and provision of resource materials (including source document verification reports and query status reports) to onsite monitors to assist with their onsite activities.
  
• Training of sites and supporting study team members on data management activities at two investigator meetings.
  
• Direct communication with site personnel to assist in resolution of queries.
  
• Design and Maintain Clinical SharePoint Sites.
  
• Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
  
• Other miscellaneous duties as may be required.
  

Required Education and Experience

• Undergraduate university Degree (4 year program), or equivalent experience (e.g. B.Sc., B. Eng)
  
• Requires a minimum of 6 â?? 10 years of related work experience with a solid understanding of Clinical Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Clinical Research Data Management or equivalent.
  
• Member of Society for Clinical Data Management (CCDM Certification preferred)
  
• International Harmonized /Committee Good Clinical Practices, IHC/GCP.
  
• Implementation of FDA Title 21 CFR Part 11 Compliant Data Systems.
  
• Implementation of Electronic Data Capture for Clinical Studies.
  
• Implementation of Clinical Trial Management Systems for Clinical Studies
  
• Knowledge of project management tools and techniques.
  
• Broad knowledge and application of business concepts, procedures and practices.
  
• Intermediate working knowledge of MS Office.
  
• Programming experience in any of the following: SAS, SAS JMP, R, Python.
  
• Excellent Communications skills, both oral and written.
  
• Ability to initiate, plan and manage projects.
  
• Strong decision-making skills and ability to prioritize.
  
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.