Job Description
Are you ready to shape the future of medicine? Novartis International AG is seeking a highly analytical and detail-oriented Senior Clinical Data Manager (CDMP) to join our elite Regulatory Affairs team in Basel. In this pivotal role, you will oversee the integrity and accuracy of critical clinical trial data, ensuring full compliance with global regulatory standards while driving operational excellence.
We are looking for a leader who doesn't just process data—they empower patient outcomes. You will collaborate with cross-functional squads of scientists, statisticians, and clinical operations experts to streamline the data lifecycle from CRF design to database lock.
Why join us?
- Competitive Compensation: CHF 115k - 145k annual package.
- Flexible Work: Hybrid model supporting a healthy work-life balance.
- Premium Benefits: Comprehensive health coverage and continuous professional development.
Responsibilities
- Lead the clinical data management lifecycle, including data validation, cleaning, and final lock strategies for complex therapeutic areas.
- Ensure strict adherence to GCP (Good Clinical Practice) and ICH E6(R2) guidelines across all projects.
- Develop and maintain comprehensive Data Management Plans (DMP) and validation documentation.
- Utilize advanced statistical tools (SAS, R, SQL) to perform root cause analysis on data queries and discrepancies.
- Manage and mentor external data management vendors and CRO relationships effectively.
- Train and mentor junior data management staff on best practices and regulatory standards.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or Computer Science (Master’s preferred).
- Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotech industry.
- Proficiency in CDISC standards (SDTM, ADaM) and data validation methodologies.
- Strong command of SAS programming or Python/R for data manipulation.
- Certification as a Clinical Data Management Professional (CDMP) or equivalent is highly desirable.
- Excellent problem-solving skills and ability to thrive in a fast-paced, deadline-driven environment.