What does a clinical data specialist do?
Clinical data specialists offer data management support for clinical trials and pharmaceutical research. These specialists review the research study and trial data. They determine the trends of data trends and verify data entry. Their job includes providing suggestions for improvement and generates reports. They disseminate information on paper into electronic data systems. They supervise the conversion process and work closely with their clients ensuring accurate and accessible data--also, the research data sources for information validity verification.
Clinical data specialist responsibilities
Here are examples of responsibilities from real clinical data specialist resumes:
- Manage clinical trial product inventory and disbursement to patients.
- Manage daily operations to strategically plan protocol studies for tandem oncology patients.
- Generate SAS code that includes SAS/Macros, SAS/GRAPH, SAS/ACCESS, etc.
- Create SAS ad-hoc reports as per requirements by the client PASTEC.
- Provide QC reviews that are complete in accordance with study specific timelines.
- Provide oversight to and communicate with contract research organizations (CRO) and vendors.
- Test data entry screens and CRF designs to ensure compliance with the protocol and guidelines.
- Provide administrative quality control/quality assurance review of all FDA submissions.
- Develop and document all data QC procedures, data validation procedures.
- Interpret, synthesize and present technical information to CRO management and pharmaceutical and biotechnology clients.
- Code adverse event and concomitant medication verbatim utilizing MedDRA and ICD-9dictionaries.
Clinical data specialist skills and personality traits
We calculated that 18% of Clinical Data Specialists are proficient in Patients, Data Collection, and Patient Care. They’re also known for soft skills such as Analytical skills, Math skills, and Communication skills.
We break down the percentage of Clinical Data Specialists that have these skills listed on their resume here:
- Patients, 18%
Managed daily operations to strategically plan protocol studies for tandem oncology patients.
- Data Collection, 10%
Worked with documentation, testing, implementing and managing clinical data collection and reporting systems.
- Patient Care, 10%
Provide direction, support, and appropriate information to patient care clinicians to facilitate and implement the patient care plan.
- Data Analysis, 9%
Supported Data Processing into multiple data bases used for outside regulatory reporting and internal operational data analysis.
- Medical Terminology, 6%
Collaborated with pertinent medical personnel, researched and validated confidential medical reports, verifying proper standard ICD-9 coding and medical terminology.
- Informed Consent, 5%
Recruit, screen, and retain eligible study participants, as well as obtain informed consent.
"patients," "data collection," and "patient care" are among the most common skills that clinical data specialists use at work. You can find even more clinical data specialist responsibilities below, including:
Analytical skills. To carry out their duties, the most important skill for a clinical data specialist to have is analytical skills. Their role and responsibilities require that "mathematicians and statisticians use mathematical techniques and models to evaluate large amounts of data." Clinical data specialists often use analytical skills in their day-to-day job, as shown by this real resume: "represent the college in various data standardization initiatives of the fda, cdc and other standards organizations. "
Math skills. Another soft skill that's essential for fulfilling clinical data specialist duties is math skills. The role rewards competence in this skill because "mathematicians and statisticians use statistics, calculus, and linear algebra to develop their models and analyses." According to a clinical data specialist resume, here's how clinical data specialists can utilize math skills in their job responsibilities: "compiled statistics using excel, used in helping diagnosis and treatment for patients. "
Communication skills. clinical data specialists are also known for communication skills, which are critical to their duties. You can see how this skill relates to clinical data specialist responsibilities, because "mathematicians and statisticians must be able to explain technical concepts and solutions in nontechnical ways." A clinical data specialist resume example shows how communication skills is used in the workplace: "used persistence and persuasive communication skills to successfully advocate for patients with insurance companies and hmos. "
Problem-solving skills. A big part of what clinical data specialists do relies on "problem-solving skills." You can see how essential it is to clinical data specialist responsibilities because "mathematicians and statisticians must devise solutions to problems encountered in science, engineering, and other fields." Here's an example of how this skill is used from a resume that represents typical clinical data specialist tasks: "reviewed case report form (crf) data for completeness, accuracy/consistency; identified/resolved data discrepancies; applied corrections to crfs. "
The three companies that hire the most clinical data specialists are:
- Bristol-Myers Squibb3 clinical data specialists jobs
- Navitus3 clinical data specialists jobs
- University of Colorado3 clinical data specialists jobs
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Compare different clinical data specialists
Clinical data specialist vs. Data management associate
A data management associate is responsible for maintaining and updating databases, spreadsheets, documents, and other data storage systems while adhering to company standards and protocols. Their daily tasks usually include gathering and organizing data, conducting reviews to identify errors or inconsistencies, taking corrective measures, and producing regular reports, presenting them to managers. They may also participate in troubleshooting issues, planning data migration procedures, and enforcing data security protocols. Moreover, a data management associate must be proactive at dealing with issues to maintain an optimal workflow.
These skill sets are where the common ground ends though. The responsibilities of a clinical data specialist are more likely to require skills like "patients," "patient care," "medical terminology," and "informed consent." On the other hand, a job as a data management associate requires skills like "data entry," "clinical data," "commercial banking," and "data integrity." As you can see, what employees do in each career varies considerably.
Data management associates really shine in the media industry with an average salary of $127,370. Comparatively, clinical data specialists tend to make the most money in the health care industry with an average salary of $73,821.data management associates tend to reach similar levels of education than clinical data specialists. In fact, data management associates are 1.4% more likely to graduate with a Master's Degree and 2.0% less likely to have a Doctoral Degree.Clinical data specialist vs. Clinical statistics manager
Clinical data management managers perform database development tests to support the clinical studies assigned to them. These managers must have collaboration and communication skills to work smoothly with other internal departments and fellow managers. They lead problem-solving in data collection, quality control, and improving their current data management process. Their job is to become a model that works and reinforces their company's vision and mission. They also ensure those project deadlines are met by organizing and distributing workloads and schedules to the staff.
In addition to the difference in salary, there are some other key differences worth noting. For example, clinical data specialist responsibilities are more likely to require skills like "patients," "patient care," "data analysis," and "medical terminology." Meanwhile, a clinical statistics manager has duties that require skills in areas such as "clinical trials," "statistical software," "python," and "sops." These differences highlight just how different the day-to-day in each role looks.
Average education levels between the two professions vary. Clinical statistics managers tend to reach higher levels of education than clinical data specialists. In fact, they're 10.4% more likely to graduate with a Master's Degree and 2.0% more likely to earn a Doctoral Degree.Clinical data specialist vs. Clinical data management manager
Specialists are employees who are responsible for specific tasks or activities in the department they are assigned to. The actions or tasks they work on are related to their educational background or work experiences. They are usually highly skilled in specializations related to the work they are assigned to. Specialists are also highly trained on the competencies that are required of their specialty. As such, they are focused on the skills and competencies that are needed to enhance their experience in their specific field further.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a clinical data specialist is likely to be skilled in "patients," "patient care," "medical terminology," and "regulatory agencies," while a typical clinical data management manager is skilled in "clinical research," "direct reports," "cdisc," and "data entry."
Clinical data management managers earn the highest salary when working in the pharmaceutical industry, where they receive an average salary of $117,753. Comparatively, clinical data specialists have the highest earning potential in the health care industry, with an average salary of $73,821.clinical data management managers typically earn higher educational levels compared to clinical data specialists. Specifically, they're 8.6% more likely to graduate with a Master's Degree, and 0.2% more likely to earn a Doctoral Degree.Clinical data specialist vs. Specialist
Types of clinical data specialist
Updated January 8, 2025
