Clinical Data Managers
Do you remember how many times you've taken medication in your life? Ten times? A hundred? A thousand? You certainly don't know — we've been receiving different medications from the very first moment we came out of our mothers' wombs and throughout our whole lives. But wait, have you ever thought about how those thousands of medications that treat nearly every human being are actually manufactured? Manufacturing even a single medication is a complicated process that can take years — there are various stages a drug goes through before it's released to market. Scientists and researchers first conduct their research and experiments to arrive at the right drug formula capable of fighting the disease, then the drug is tested on animals, and after that comes a stage called "clinical trials," which means testing the new drug on a small number of volunteer patients, then a larger number, then an even larger number, until the drug's effectiveness is confirmed. All this research and these trials, clinical and otherwise, can take years, and they produce huge amounts of information and data that must be recorded promptly in precise documents and databases so it can always be easily found and so no mistakes happen during the manufacturing stages. Government bodies responsible for drug manufacturing in any country also need to review all the data related to a drug's manufacturing stages before approving its release to market. So there's an entire team that, from the very first moment trials begin, records all the results and organizes them precisely in specific databases, and their work continues through every stage until manufacturing is complete. Today we'll talk about the leader of this team, called the "clinical data manager" — who doesn't just oversee the recording of all data and results, but also monitors everything researchers do during trials, especially during the clinical trial stage, which is subject to strict rules set by government bodies.
Meet the Writer: Waleed Abo Omiraa
What You'll Actually Do
The core tasks and responsibilities that fill a typical day.
- Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices.
- Prepare appropriate formatting to data sets as requested.
- Evaluate processes and technologies, and suggest revisions to increase productivity and efficiency.
- Develop technical specifications for data management programming and communicate needs to information technology staff.
- Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
- Write work instruction manuals, data capture guidelines, or standard operating procedures.
- Track the flow of work forms, including in-house data flow or electronic forms transfer.
- Train staff on technical procedures or software program usage.
- Supervise the work of data management project staff.
- Prepare data analysis listings and activity, performance, or progress reports.
- Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
- Monitor work productivity or quality to ensure compliance with standard operating procedures.
- Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
- Design and validate clinical databases, including designing or testing logic checks.
- Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.
- Analyze clinical data using appropriate statistical tools.
- Process clinical data, including receipt, entry, verification, or filing of information.
- Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and work flow processes.
- Design forms for receiving, processing, or tracking data.