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Clinical Data Management Jobs in Reston, VA (NOW HIRING)

VENESCO, LLC

SAS Programmer

Falls Church, VA · On-site +1

... data management teams Support regulatory submissions and audits Minimum Qualifications: Bachelor's or Master's degree in Statistics or related field 5+ years of SAS programming experience in clinical ...

VENESCO LLC

SAS Programmer

Falls Church, VA · On-site

Venesco is seeking a skilled SAS Programmer to support clinical data analysis and regulatory ... data management teams • Support regulatory submissions and audits Minimum Qualifications: • ...

Venesco LLC

SAS Programmer

Falls Church, VA · On-site

Venesco is seeking a skilled SAS Programmer to support clinical data analysis and regulatory ... data management teams • Support regulatory submissions and audits Minimum Qualifications: • ...

Core4ce

Clinical Terminologist

Reston, VA

Support healthcare interoperability initiatives by ensuring consistent semantic representation across clinical systems, applications, and data exchanges. * Utilize terminology management tools to ...

New

REGENXBIO

Sr Clinical Project Manager

Rockville, MD · On-site

Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues and queries as needed and implements risk management concept as ...

REGENXBIO

Sr Clinical Project Manager

Rockville, MD

Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues and queries as needed and implements risk management concept as ...

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Clinical Data Management information

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How much do clinical data management jobs pay per hour?

As of Jun 13, 2026, the average hourly pay for clinical data management in Reston, VA is $59.47, according to ZipRecruiter salary data. Most workers in this role earn between $47.02 and $70.77 per hour, depending on experience, location, and employer.

What is the work of clinical data management?

Clinical data management involves collecting, cleaning, and maintaining data from clinical trials to ensure accuracy, completeness, and consistency. It includes designing data collection tools, validating data, and generating reports, often using specialized software like EDC systems. This role requires attention to detail and knowledge of regulatory standards such as GCP and FDA guidelines.

What is clinical data management?

Clinical data management (CDM) is a critical process in clinical research that involves collecting, cleaning, and managing data generated during clinical trials. The goal is to ensure that the data is accurate, reliable, and compliant with regulatory standards. CDM professionals work closely with researchers, statisticians, and regulatory bodies to validate data and ensure its integrity throughout the study. This process helps in making informed decisions about the safety and efficacy of new drugs or treatments.

What are some common challenges faced by professionals in Clinical Data Management, and how can they be addressed?

One of the common challenges in Clinical Data Management is ensuring data accuracy and consistency across multiple sources and formats. This often involves resolving discrepancies and managing large volumes of data within tight timelines. Effective communication with clinical research associates, statisticians, and IT teams is crucial to address data queries promptly and maintain data integrity. Staying updated with regulatory requirements and leveraging advanced data management systems can also help mitigate these challenges and improve overall workflow efficiency.

What is the difference between Clinical Data Management vs Clinical Data Coordinator?

AspectClinical Data ManagementClinical Data Coordinator
ResponsibilitiesDesigning data collection processes, database setup, data validation, and ensuring data quality for clinical trials.Collecting, reviewing, and entering clinical trial data, ensuring accuracy and completeness.
Required SkillsKnowledge of data management systems, clinical trial processes, and data validation techniques.Attention to detail, data entry skills, familiarity with clinical trial documentation.
Work EnvironmentTypically in clinical research organizations, pharmaceutical companies, or CROs.Often within clinical sites or research teams supporting data collection activities.

While both roles focus on clinical trial data, Clinical Data Management involves designing and overseeing data systems and ensuring data integrity, whereas Clinical Data Coordinators handle the day-to-day data collection and entry tasks. Both are essential for successful clinical research but differ in scope and responsibilities.

Is clinical data management a good career?

Clinical data management is a vital role in the healthcare and pharmaceutical industries, involving the collection, validation, and analysis of clinical trial data. It offers opportunities for career growth, requires knowledge of data management tools like EDC systems, and often benefits from certifications such as CDMP. The field provides stable employment with increasing demand due to the growth of clinical research activities.

Is CRA an entry-level job?

A Clinical Research Associate (CRA) is typically not an entry-level position; it usually requires prior experience in clinical research, monitoring, or related fields. Entry-level roles in clinical data management or clinical research support may serve as stepping stones toward becoming a CRA, often requiring knowledge of Good Clinical Practice (GCP) and relevant certifications. Most CRAs are expected to have a background in life sciences, healthcare, or related disciplines, along with strong organizational skills and attention to detail.

What are the key skills and qualifications needed to thrive in Clinical Data Management, and why are they important?

To thrive in Clinical Data Management, you need a strong background in life sciences, attention to detail, and understanding of clinical trial processes, often supported by a relevant degree. Familiarity with industry-standard data management systems such as Medidata Rave or Oracle Clinical, as well as knowledge of CDISC standards and regulatory requirements, is essential. Excellent organizational skills, communication, and problem-solving abilities help ensure data integrity and effective cross-functional collaboration. These skills and qualities are crucial for ensuring high-quality, compliant data that supports clinical research and regulatory submissions.

How do I become a Clinical Data Manager?

To become a Clinical Data Manager, typically a bachelor's degree in life sciences, healthcare, or a related field is required. Relevant skills include knowledge of clinical trial processes, data management tools like EDC systems, and attention to detail; certifications such as CDMP can enhance job prospects. Gaining experience through internships or entry-level roles in clinical research is also beneficial.
What are popular job titles related to Clinical Data Management jobs in Reston, VA? For Clinical Data Management jobs in Reston, VA, the most frequently searched job titles are:
What job categories do people searching Clinical Data Management jobs in Reston, VA look for? The top searched job categories for Clinical Data Management jobs in Reston, VA are:
What cities near Reston, VA are hiring for Clinical Data Management jobs? Cities near Reston, VA with the most Clinical Data Management job openings:
Clinical Data Management jobs near you
Clinical Data Scientist, FDA (Mid)

Clinical Data Scientist, FDA (Mid)

DRT Strategies, Inc.

Silver Spring, MD • On-site

$95K - $125K/yr

Full-time

Posted 11 days ago

Job description

Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description:
The Clinical Analyst contractor position provides scientific and clinical analytical support to CDER Office of New Drugs (OND) multi-disciplinary review teams. The individual will assist in the evaluation of drug applications, review clinical safety data, labeling assessment, and preparation of scientific reports. The work requires advanced knowledge in health and data sciences and
the ability to apply scientific expertise to support risk determinations in the context of regulatory review.
Note: This is a support role. All regulatory decisions, final recommendations, and official communications with applicants remain the exclusive responsibility of qualified FDA
federal employees. The contractor's work products are subject to review and approval by FDA staff.
Job Summary:
The Clinical Analyst position interacts with many FDA stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers. This role will be responsible for reviewing safety data sufficiency and integrity, conducting safety data analyses, verifying safety data submitted by the applicant, and generating high-quality scientific reports.
Responsibilities:
Clinical Data Analysis and Review
  • Analyze and evaluate submitted data from applicants seeking permission to market new drugs for general use and prepare analytical summaries on the adequacy of safety data provided.
  • Review NDAs, BLAs, supplements, and amendments; prepare draft analytical reports and recommendations for FDA reviewer consideration.
  • Incorporate summaries from clinical safety data reviews as part of integrated multi- disciplinary assessments. Prepare, oversee, and maintain project schedules.
Labeling Review Support
  • Assist in the review of proposed drug labeling to assess whether safety claims are truthful and adequately supported.
  • Provide draft safety data analysis on labeling accuracy and completeness for review by FDA staff.
Scientific Correspondence and Reporting
  • Draft scientifically sufficient reports of findings that clearly communicate clinical safety analyses and conclusions.
  • Prepare draft correspondence identifying facts and information inadequately presented in sponsor submissions, for FDA reviewer finalization and issuance.
  • Prepare clear summaries of clinical safety data tables, figures and listings for FDA review team use.
Literature Review and Knowledge Management
  • Review scientific literature and maintain awareness of current clinical developments and evolving findings in relevant therapeutic areas.
  • Support preparation of background materials for seminars, conferences, and industry meetings.
  • Stakeholder Support
  • Support clinical review teams in preparing for meetings with drug company representatives, advisory committees, and external scientific bodies.
Other Tasks
  • Lead meetings with clinical reviewers and statistical reviewers to present results from data quality assessments and standard safety data analyses.
  • Collaborate with CDER OND staff to optimize team processes and deliverables.
  • Work with FDA stakeholders to review background packages and mock safety datasets to assess appropriateness of controlled terminology and safety dataset structure.
  • Interact with government and contractor teams to help manage and monitor project progress, risk, issues, and track action items.
  • Manage, organize, and update SharePoint sites.
  • Assist in overall project support, as needed.
  • Support any other DRT tasks as assigned/requested by Portfolio Manager and Account Lead.
Required Experience:
  • PhD or PharmD with minimum of 3 years professional experience.
  • Technical proficiency in programming languages- R (mandatory) with demonstrated experience using R for data manipulation, analysis, and visualization in a clinical or regulatory research context.
  • R programming - ability to troubleshoot errors in R.
  • Experience with CDISC data standards (including SDTM and ADaM) and safety dataset structure (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt)
  • Understands data analytical methods (e.g., longitudinal analysis, time-to-event analyses, and causal/correlation analyses) for conducting safety data analyses (tables and figures)
  • Understands safety review elements including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, and vital signs. Working knowledge of safety analysis methods, including the evaluation of adverse event data, safety signal detection, and the preparation of standardized safety tables and figures.
  • Strong analytical and statistical skills to assess safety data.
  • Excellent organizational, time management, verbal and written communication skills.
  • Ability to independently manage a variety of projects with frequent interruptions and shifting priorities.
  • Ability to organize a continuous flow of work in a timely manner and meet mandatory deadlines.
  • Computer skills: MS Office Suite (particularly PowerPoint, Word, Excel), Adobe Acrobat.
  • Ability to work independently within a multidisciplinary team.
Preferred Experience:
  • Proficiency in manipulating data using R programming.
  • Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc.
  • Experience in SAS programming.
  • Ability to apply knowledge of scientific research principles, study design concepts, and methods sufficient to evaluate clinical drug development programs.
  • Experience in applying clinical safety data analytical skills, including the ability to synthesize clinical and scientific evidence to inform risk assessments.
  • Experience in clinical trials, especially statistical hypothesis testing methods. Understands general concept of clinical trial design and drug development (e.g., adequate and well-controlled studies).
  • Statistical background, including experience with biostatistical methods commonly
    applied in clinical trial design, analysis, and interpretation (e.g., survival analysis, mixed-
    effects models, hypothesis testing).
  • Machine learning and AI background, including familiarity with predictive modeling
    techniques (e.g., classification models, regression models, random forest, or neural
    networks) and their potential applications in drug safety evaluation and regulatory science.
  • Epidemiological background, including experience with observational study design, real-
    world evidence, pharmacoepidemiology, or population-level safety surveillance methods.
  • Ability to work with little direct supervision on loosely defined tasks and coordinate work across multiple projects.
  • Experience identifying, articulating, and resolving complex, unique, and previously unresolved.
  • Familiarity with FDA regulatory process and/or working experience at FDA.
Education & Training:
  • PhD/PharmD or equivalent degrees are preferred.
Work Authorization, Clearance Requirement, & Additional Information:
  • This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
  • No agencies, third parties, or Corp-to-Corp submissions.
Salary Range:
  • $95,000-125,000
  • Salary commensurate with experience.

DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).
Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at hr@drtstrategies.com if you believe you have received a fraudulent email.

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