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.
- 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.