The CRA Training Institute

The Clinical Data Manager (CDM) plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.

The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the clinical data manager ensures that data is collected, validated, complete and consistent.

Upon completion of the course participants will be able to:

• Process and analyze data collected from the Clinical Trial (pharmaceuticals, biologics, or devices).
• Coordinate 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.
• Provide Clinical data management support Clinical Data Management team and Biostatistics team.
• Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports).
• Develop Data Management Plan (DMP), maintains DMP throughout life-cycle of study project.
• 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).
• Coordinate UAT of eCRF build and validation documents.
• Edit check document, issue logs, UAT summary report.
• Maintain/track EDC user management and other Clinical databases across allocated Clinical trials.
• Compile master user lists and activate/deactivate 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, data reconciliation and/or coding. 
• Assist in defining and/or create data listings, summary table validation, data specifications and/or process
• Transfer data 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
• Plan projects, and/or eCRF development activities.
• Collaborate with IT and implementation team(s) to address Clinical application requests
• Collaborate with IT and implementation team(s) to address changes to Clinical database systems.
• Participate in the preparation and presentation of data, when applicable.
• Ensure data system compliance by following the established guidelines of 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.
• Your resume will have industry-specific terminologies that will guarantee that you get interviews.
• Graduates are routinely referred to employers who contact us regularly when looking to hire CDMs.
• Our graduates are given lifetime access to our exclusive Clinical Research jobs database.
• Recruiters and Employers post their entry-level and other CDM jobs to our exclusive jobs database.