Preparing Professionals for Clinical Research Since 1989
The CRA Training Institute

The CRA Training Institute

 

Course Enrollment

CDM Certificate course

$1,390.00

Managing Clinical Data

Tuition fee:   $1390.00

The Responsibilities of the CDM include:

  • Processing and analysis of data collected from the Clinical Trial (pharmaceuticals, biologics, or devices).
  • The CDM is responsible for timelines, reporting and data collection.
  • Coordinates the receipt and processing of information for projects (e.g., coding dictionaries)
  • Electronic data capture.
  • Ensure databases are validated and ready for transfer and/or analyses.
  • Provide Clinical data management support to Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team.
  • Participates in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).
  • Develops 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
  • Develops 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 activites.
  • Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.
  • Participates in the preparation and presentation of data, when applicable.
  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
  • Participate in conference calls and/or meetings with vendors.

Students will participate in many online simulation exercises during the training program that will expose you to actual clinical data management situations.

With the knowledge and job skills gained as a result of your study, you can help to meet the ever-growing demand for trained CDMs to develop exciting new therapeutics for the 21st century in the biotechnology, pharmaceutical and medical device industries.

The CDM certificate course is recognized internationally in all the countries that are signatories to the ICH-GCP guidelines for clinical trials. This includes USA, Canada, Israel, Germany, Switzerland, Italy, UK, France, EU countries, Russia, Ukraine, Czech Republic, China, Spain, India, Japan, Hong Kong, Australia, New Zealand, Singapore, South Africa and many others.

Job Placement Assistance:

  • As a graduate you will receive assistance to update your resume to include your new qualifications using the appropriate industry-specific terminologies that will guarantee that you get interviews.
  • Our graduates are routinely referred to employers and recruiters who contact us regularly when looking to hire CDMs.
  • Our graduates are given lifetime access to our exclusive jobs database where Recruiters and Employers post their entry-level and other CDM jobs in order to attract our graduates.

Training Duration - 200 CEUs:
• 100% Online, Self-Paced Training, Start Anytime from Anywhere.
• Average completion time - 2 to 3 months studying part-time.
• Actual completion time varies depending on your pace of study.

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