MSD ir globāls biofarmācijas uzņēmums, kas izstrādā zāles un vakcīnas nozīmīgu veselības problēmu risināšanai, tostarp vēža, infekcijas slimību, sirds un asinsvadu slimību un vielmaiņas traucējumu ārstēšanai, kā arī pievēršas profilaktiskajai aprūpei. Amerikas Savienotajās Valstīs, Kanādā un Puertoriko MSD ir pazīstams kā Merck & Co., Inc. MSD apvieno zinātnisko pētniecību ar izstrādes un komerciālo kompetenci, lai veselības aprūpes risinājumi būtu pieejami cilvēkiem un dzīvniekiem.
Uzņēmuma darbība aptver cilvēku veselību, dzīvnieku veselību, kā arī pētniecību un izstrādi, radot iespējas profesionāļiem zinātnes, klīniskajā, komerciālajā, operacionālajā un uzņēmuma funkciju jomā. MSD darbojas dažādos pasaules reģionos, un tās karjeras iespējas atspoguļo koncentrēšanos uz pētniecību, sadarbību, iekļaušanu un atbildīgu globālās veselības attīstību.
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.
Apraksts
- 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.
Prasības
- 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%.
Priekšrocības
- 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.