Job Description
We are seeking a visionary Senior Clinical Data Manager to join our elite team in Basel. You will be at the helm of our data integrity strategy, ensuring that our groundbreaking therapies reach patients safely and efficiently.
Why join us?
- Work with cutting-edge technology in a state-of-the-art facility.
- Competitive compensation and equity packages.
- Opportunity to mentor junior staff and drive process improvement.
The Role:
You will oversee the entire clinical data lifecycle, from source data verification to database lock, ensuring the highest standards of data quality and regulatory compliance.
Responsibilities
- Oversee the entire clinical data lifecycle from source data verification to database lock.
- Ensure strict compliance with ICH-GCP guidelines and local regulations (21 CFR Part 11).
- Lead initiatives for data quality improvement and error reduction.
- Collaborate with cross-functional teams including statisticians, medical writers, and CROs.
- Prepare comprehensive documentation for regulatory audits and submissions.
- Implement and maintain data management systems (e.g., Rave, OpenClinica).
Qualifications
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical industry.
- Advanced proficiency in data management software (Rave, SAS, R, or SQL).
- Strong understanding of E2B data standards and electronic signatures.
- Excellent communication skills and ability to work in a fast-paced, international environment.
- Relevant certification (ACDM, RAC) is a plus.
- Fluency in English and German is highly desirable.