Job Description
Title: Clinical Data Analyst Location: Plymouth, MN
Duration: 12 months on W2 (100% Onsite)
Position Summary The Clinical Research Specialist is responsible for managing and integrating clinical data across studies. This role bridges clinical data operations and scientific writing, ensuring high-quality data and regulatory-compliant deliverables that support product safety, performance, and continued market access.
Key Responsibilities - Clinical Data Management & Integration
- Collect, monitor, and validate clinical trial and post-market data from multiple sources.
- Support risk-based monitoring and centralized data review processes.
- Collaborate with cross-functional teams to ensure data quality, traceability, and readiness for analysis.
- Data Analysis & Reporting
- Generate data summaries, visualizations, and reports to support clinical study outcomes and PMCF activities.
- Assist in interpreting real-world data (RWD) and integrating it into post-market clinical follow-up (PMCF) documentation.
- Participate in ongoing data surveillance and contribute to the development of tools for ongoing data surveillance.
- PMCF Medical Writing
- Draft and maintain PMCF Plans, PMCF Evaluation Reports, and associated documents in accordance with EU MDR and MEDDEV 2.7/1 Rev. 4.
- Review clinical evaluation documents (e.g. CEPs, CERs, PSURs) for scientific and clinical accuracy
- Translate clinical data into clear, scientifically sound narratives that support regulatory submissions and business needs.
- Conduct literature reviews and integrate findings into PMCF documentation.
- Collaborate with regulatory, clinical, biometrics, and quality teams to ensure alignment with global requirements.
Qualification - Bachelor’s degree in Life Sciences, Health Informatics, Clinical Research, or related field
- 3+ years of experience in clinical data management, clinical research, or medical writing.
- Familiarity with PMCF requirements, EU MDR, and clinical evaluation processes.
- Proficiency in MS Excel and MS Word
- Experience with SQL or other database technology.
- Demonstrated scientific writing ability.
- Strong written communication skills and attention to detail.
- Ability to work independently and collaboratively in a cross-functional environment.
- Be able to manage multiple projects and priorities simultaneously.
Preferred Skills - Prior experience writing PMCF or CER documents.
- Familiarity with regulatory writing tools (e.g., EndNote, Zotero, Distiller SR).
- Proficiency in data analysis tools such as Matlab or Minitab.
- Research experience in statistics/data science/related fields.
Consultants Eligible Benefits Upon Waiting Period - Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High-Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
Job Tags
Temporary work, Flexible hours,