MSD je globalno biofarmacevtsko podjetje, ki razvija zdravila in cepiva za reševanje ključnih zdravstvenih izzivov, vključno z rakom, nalezljivimi boleznimi, srčno-žilnimi in presnovnimi stanji ter preventivno zdravstveno oskrbo. V Združenih državah Amerike, Kanadi in Portoriku je znano kot Merck & Co., Inc. MSD združuje znanstvene raziskave s strokovnim znanjem na področju razvoja in trženja, da bi zdravstvene rešitve približalo ljudem in živalim.
Njegovo delo zajema zdravje ljudi, zdravje živali ter raziskave in razvoj, kar ustvarja priložnosti za strokovnjake v znanstvenih, kliničnih, komercialnih, operativnih in korporativnih ekipah. MSD deluje v regijah po vsem svetu, njegove karierne priložnosti pa odražajo osredotočenost na raziskave, sodelovanje, vključevanje in odgovoren napredek na področju globalnega zdravja.
Clinical Data Management Specialist
Validate clinical databases and electronic data capture systems for MSD, carrying out quality control and user acceptance testing. Document results in line with standard operating procedures and ICH-GCP guidelines.
Opis
- Create and run quality control and user acceptance tests.
- Test electronic data capture systems, clinical data review reports, and data management databases.
- Validate web-based EDC platforms, electronic devices and diaries, and COA, IVRS, and IWRS systems.
- Record testing outcomes clearly and accurately.
- Work with functional teams to apply database standards appropriately.
- Keep database, data collection, review, and retrieval specifications consistent across projects.
- Develop standard and study-specific test scripts.
- Review colleagues’ user acceptance testing documentation.
- Follow company SOPs and ICH-GCP guidelines in all work.
Zahteve
- Bachelor’s degree, preferably in mathematics, science, a healthcare-related field, or computer science.
- At least two years of knowledge of system development lifecycle management or system validation.
- Knowledge of database design and development.
- General understanding of the clinical development process.
- Preferred: familiarity with database structures and tools for managing, extracting, and reporting data.
- Excellent spoken and written communication skills.
- Strong organization and problem-solving skills.
- Ability to collaborate across functions and contribute to a team.
- Ability to work under pressure and adapt flexibly to changing conditions.
- Knowledge of system development lifecycle management or system validation.
- Familiarity with Python, Java, C#, Jira, Power BI, GitHub, and SQL.
- Knowledge of clinical data management, data analysis, database development, data processing, data quality assurance, data validation, data visualization, EDC, and PL/SQL.
- Must live in the United States or Puerto Rico.
- Visa sponsorship is not available.
- Ability to travel 10%.
Ugodnosti
- Annual bonus and, where applicable, long-term incentive compensation.
- Medical, dental, and vision coverage.
- Additional insurance coverage for employees and their families.
- Retirement benefits, including a 401(k) plan.
- Paid holidays.
- Vacation leave.
- Compassionate and sick leave.
- Flexible hybrid work arrangement.