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Clinical Data Coordinator, Clinical Data Manager, Clinical Research Data Analyst, Clinical Research Coordinator, Clinical Informatics Specialist, Healthcare Data Analyst, Clinical Data Scientist, Clinical Data Administrator, Clinical Data Quality Specialist, Clinical Trial Data Manager

작업 설명

If you’ve ever taken a medication, you probably didn’t think much about how it worked.

But most likely, it took a decade of expensive research and clinical trials before that medication was approved for use. During this lengthy research and development (R&D) process, pharmaceutical companies employ a wide range of experts such as pharmacologists, biochemists, toxicologists—and Clinical Data Specialists!

Clinical Data Specialists play a crucial role in managing and analyzing large amounts of data from clinical trials to ensure accuracy, integrity, and compliance with regulatory standards. They’re crucial to the R&D process and their work provides invaluable insights into the safety and efficacy of new drugs, treatments, and medical devices. They also prepare detailed reports to the U.S. Food and Drug Administration (FDA) to assist with its decision-making processes of what to approve or not.

경력의 보람있는 측면
  • Conducting research and providing findings that impact the medical industry
  • Working to improve patient treatments and outcomes
  • Helping to ensure unsafe medications and treatments are not approved
2022년 채용 정보
2032년 예상 고용
인사이드 스쿱
직무 책임

근무 일정

  • Clinical Data Specialists work full-time, with the possibility of irregular hours depending on project deadlines. Remote work may be possible, depending on the employer.

일반적인 의무

  • Facilitate clinical trial planning and execution with project managers

    Track clinical trial participant timelines
  • Design and implement secure databases and systems for clinical trial data collection and storage
  • Collect data from sources like health records, laboratory tests, medical reports
  • Input data and monitor data quality for completeness, accuracy, and consistency. Fix errors and fill in missing information
  • Consult with data managers on edits and inconsistencies
  • Analyze data using statistical methods to identify trends
  • Protect the integrity and confidentiality of clinical data
  • Assess and record adverse events listed in medical records for clinical trials
  • Comply with privacy laws, regulatory requirements, and ethical best practices
  • Prepare reports, summaries, and visualizations to communicate findings and insights
  • Coordinate with researchers and healthcare professionals to use findings effectively

추가 책임

  • Train clinical research teams in data collection and management protocols
  • Contribute to scientific presentations
  • Supervise and train interns and junior personnel in data-handling practices
  • Serve as a liaison between study sponsors and institutional review boards
  • Help to integrate document management and clinical operation tools
  • Stay up-to-date on data management technology, research methodologies, and regulatory guidelines
직업에 필요한 기술

소프트 스킬

  • 적응성
  • 분석
  • 세부 사항에주의
  • 공동
  • 비판적 사고
  • 호기심
  • 근면
  • Ethical judgment
  • 독립
  • Interpersonal and communication skills
  • Problem-solving ability
  • Strategic planning
  • 시간 관리

기술 능력

Clinical Data Specialists will need technical skills related to the following:

  • Clinical data management systems and software (e.g., Oracle Clinical, Medidata Rave, and SAS)
  • Data interpretation
  • Data privacy and security practices (such as encryption, access controls, and audit trails)
  • Electronic health records (such as Epic and Cerner)
  • Healthcare regulations and compliance standards (HIPAA, GDPR, and ICH GCP)
  • Informed consent
  • Medical terminology and healthcare processes
  • Reporting tools (like SPSS and R)
  • 통계 분석
  • SQL programming language
  • Working with regulatory agencies 
다양한 유형의 조직
  • Hospitals and healthcare systems
  • Clinical research organizations
  • Biotechnology and pharmaceutical companies
  • Government and public health departments
기대와 희생

Being a Clinical Data Specialist requires patience, diligence, and a commitment to accuracy. Even small details can have big impacts when it comes to the type of research and clinical trials they’re involved with.

Their work may help a much-needed medication get FDA approval, potentially affecting the health outcomes of millions of patients. Though their findings can also affect the financial gains or losses of their employer, they must remain objective and ensure the accuracy and integrity of the data they use, the research they conduct, and the conclusions their findings may lead to!

현재 동향

Clinical data research is changing thanks to technological advancements and the increasing focus on tailored medical treatments. A key trend is the use of big data analytics and artificial intelligence to analyze complex health datasets. This helps to reveal patterns that lead to innovative disease treatments.

Wearable technology and mobile health applications are producing a wealth of real-time data, offering new insights into patient behavior and chronic disease management outside of hospitals and clinical settings.

New strategies are putting patients at the heart of the research and care continuum. The use of patient-reported outcomes and insights from electronic health records is making research more relevant to patient needs, speeding up the application of discoveries in clinical practice.

Data privacy and security concerns are growing due to the surge in data volume and the international nature of research collaboration. Stricter regulations are being adopted to safeguard patient data through encryption and secure data-sharing practices.

이 직업에 종사하는 사람들은 어렸을 때 어떤 종류의 일을 즐겼습니까?

People in this career often enjoyed science, math, and solving puzzles or logical challenges. They likely had a strong interest in technology, experimenting with computers and software from a young age. Many also showed a keen desire to help others in their youth.

교육 및 훈련 필요
  • Clinical Data Specialists need a blend of education and hands-on experience in healthcare data management. Internships in hospitals, clinics, or research labs help gain practical experience
  • Employers typically seek candidates with a bachelor’s degree in health informatics, health information management, health care administration, biology, nursing, public health, or a related field. Some workers may be able to get started with an associate degree, though!
  • Common college course topics may include:
  1. Biostatistics and Data Analysis
  2. Clinical Trials Management
  3. Healthcare Information Systems
  4. Health Data Management
  5. Medical Terminology
  6. Privacy and Security in Healthcare
  7. Public Health Informatics
  8. Quality Improvement in Healthcare
  • 선택적 인증에는 다음이 포함됩니다.
  1. Society for Clinical Data Management - Certified Clinical Data Manager
  2. American Health Information Management Association -

         Certified Health Data Analyst

         Registered Health Information Administrator

대학에서 찾아야 할 것들
  • There are many college majors to choose from, with countless schools to choose from. Consider majoring in health informatics, health information management, health care administration, biology, nursing, public health, or a related field.
  • Look for programs with opportunities for hands-on experience through internships or co-op programs.
  • Review faculty biographies and the program’s current research related to healthcare data management and informatics.
  • See if the school has connections to healthcare facilities for practical experience and job placement.
  • Consider the affordability of the program and the availability of financial aid and scholarships!
  • Decide if you want to attend in-person, online, or via a hybrid program. Hybrid may be a good option for those who need the flexibility of online classes but also want to get some real-world, hands-on experience.
고등학교와 대학에서해야 할 일
  • In high school, focus on subjects like biology, computer science, mathematics, statistics, and health sciences. Knock out Advanced Placement courses to prepare for college
  • Before applying for a college major, consider getting a feel for the subject matter through some short online courses. Coursera, edX, and other sites offer introductory courses in clinical data management, health informatics, or other relevant topics!
  • Decide on your college major and seek programs that offer hands-on experience, as well as courses in data analysis, clinical database software, and programming languages like Python or R
  • Seek internships or part-time jobs in healthcare settings, research labs, or with data management teams
  • Join health informatics, biostatistics, or science-related clubs to learn and make friends
  • Go to healthcare-related conferences, seminars, and workshops to network and keep up with trends
  • Regularly review scientific journals. Follow healthcare and data management blogs, podcasts, and social media accounts
  • Keep a record of your achievements, projects, and skills for your resume
  • Connect with professionals in the field for guidance
  • Figure out how you want to serve as personal references and get their permission to give out their contact information
Clinical Data Specialist Roadmap
Clinical Data Specialist Roadmap
1차 직장에 도착하는 방법
  • Visit your school’s career center for help preparing resumes and doing mock interviews
  • Apply for entry-level positions, internships, work placements, or even apprenticeships to get experience if needed
  • Update your LinkedIn profile and ask industry professionals in your network for job tips
  • Network at healthcare IT and informatics conferences, events, and job fairs
  • Review postings on Indeed, Glassdoor, and other job portals
  • Note the keywords in job ads and incorporate them into your resume where possible, to help it get through applicant tracking system programs! Common keywords might include:
  1. Clinical Trials
  2. 데이터 분석
  3. Database Design
  4. Data Integrity
  5. Data Management
  6. 데이터 마이닝
  7. Electronic Data Capture
  8. Quality Assurance
  9. Regulatory Compliance
  10. Statistical Analysis
사다리를 오르는 법
  • Plan out your career goals for the next 5, 10, and 20 years. Then ask your supervisor for help and advice on how you can reach those goals
  • Continue your professional development through continuing education classes, advanced certifications, and/or a higher-level degree
  • Offer to work on or manage more complex projects
  • Keep up with software advancements related to data analysis
  • Maintain strong relationships with other researchers and healthcare professionals
  • Consider specializing in a niche area such as Real-World Evidence Research, Health Economics and Outcomes Research, pharmacogenomics data analysis, or medical imaging data analysis
  • Stay active in professional organizations like the American Health Information Management Association. Offer to give presentations at workshops and seminars
  • Pursue leadership and management roles, like leading a team or managing a department
  • Publish findings in reputable journals. Collaborate on research proposals and seek funding for research activities
  • Specialize in cutting-edge technologies such as artificial intelligence, machine learning, and blockchain
  • Develop a personal brand and establish yourself as a thought leader
  • If needed to advance, consider relocating to look for jobs at larger organizations 
계획 B

Clinical data research is a rapidly evolving area thanks to the advent of AI, machine learning, and automation. There will still be jobs in the future for these career fields, but it’s a bit uncertain how they'll be affected by technological advancements. Most likely, Clinical Data Specialists will need to keep up with the changes to stay employable, as outdated methods get replaced.

Curious about some similar career options with related skill sets? Then check out the list below!

  • 문서 관리 전문가
  • File Clerk
  • Health Information Technologist
  • Information Clerk
  • Medical and Health Services Manager
  • Medical Registrar
  • Medical Secretary
  • 의료 전사 전문가
  • Medical Transcriptionists
  • Patient Representative
  • 약국 기술자
  • Statistical Assistant

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