Clinical Data Manager
What does the Clinical Data Manager (CDM) do?
The Clinical Data Manager plays a key role in
the setup and conduct of a clinical trial by ensuring that data is collected,
validated, complete and consistent. 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 CDM 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.
The Clinical Data Manager job description requires that he/she liaises with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data manager transfers data for statistical analysis.
Clinical Data Manager Responsibilities:
- Serves as the primary Clinical Data Management contact with sponsors and represents CDM on project teams.
- Responsible for timelines, reporting and data collection.
- Coordinates the receipt and processing of information for projects (e.g., coding dictionaries) as well as electronic data capture.
- Ensure databases are validated and ready for transfer and/or analyses.
The relevant minimum requirements to begin a career in clinical data management include the following:
- A database specialist degree, a Bachelor's degree in computer science or other information technology (IT) field.
- Previous data entry experience and intermediate level skills using a range of software applications (such as Oracle, Oracle Clinical, SAS, SQL, PowerPoint, MS Excel, MS Word, and MS Access) is required.
- Excellent interpersonal, communication and problem solving skills are required.
- Data management systems knowledge and experience is also required.
- ICH GCP (Good Clinical Practice - international guidelines) knowledge is essential.
- A graduate with no previous relevant experience is more likely to enter the profession at an entry- level responsibility, such as a clinical data coordinator.
What are CDM Salaries?
All salary information will depend on experience and the needs of the hiring companies. Typical starting salaries for new CDMs are around $80,000 and higher. Salaries quickly rise with experience. With a couple years experience, you can expect to earn between $90,000 and $95,000.