Clinical Data Manager

Teleflex Switzerland seeks a Clinical Data Manager in Bülach to oversee data management functions, ensuring compliance with GCP and MDR standards through EDC and SAS programming.

This position serves as a key component of the Clinical Operations team, managing the entire lifecycle of clinical data from study initiation to close-out. The role demands a solid grasp of Electronic Data Capture (EDC) systems and the regulatory frameworks governing clinical trials.

Responsibilities

• Collaborate on the creation of protocols and essential study documentation.
• Design electronic case report forms (eCRFs), including programming edit checks, query logic, and database specifications within the EDC system.
• Apply CDISC/SDTM standards to eCRFs to maintain data consistency and regulatory compliance.
• Execute data processing and validation tasks using SAS programming.
• Coordinate the review of eCRFs, edit rules, and database specifications with the study team.
• Prepare and execute User Acceptance Testing (UAT) scripts, logging results and engaging study teams for participation.
• Draft eCRF Completion Guidelines tailored to study designs to promote high-quality data entry.
• Create and update the Data Management Plan (DMP) throughout the study lifecycle.
• Handle in-stream data cleaning and validation for internal studies, including interim analyses and final database locks.
• Produce reports on study metrics such as query management, site performance, and source data verification (SDV).
• Review and approve Data Management Plans, CRF Completion Guidelines, and external data transfer agreements.
• Deliver training on DMP and EDC processes to internal staff and clinical sites, while maintaining training manuals.
• Organize continuous data reviews to ensure timely, high-caliber data collection alongside monitoring activities and database locks.
• Conduct regular clinical trial data reviews with monitoring teams to ensure adherence to GCP, 21 CFR Part 11, ISO 14155, and MDR requirements.

Requirements

• A Master’s degree in medicine, life sciences, natural sciences, mathematics, or computer science is preferred; a Bachelor’s degree with relevant experience is also acceptable.
• Two to three years of professional experience in clinical data management or a related discipline.
• Proven ability to develop and maintain data validation plans and associated documentation.
• Strong knowledge of Good Clinical Practice (GCP), ISO 14155, MDR, and 21 CFR Part 11 compliance standards.
• Fluent proficiency in written and spoken English.

Nice to have

• Experience implementing CDISC/SDTM standards.
• Programming skills in SAS, along with working knowledge of SQL, R, and Python.
• Basic proficiency in the German language.

What the company offers

• Flexible working hours to support work-life balance.
• Option for mobile working up to 40% of the time.
• At least 25 days of annual leave.
• A paid day off on the Friday following Ascension.
• Opportunities for training and professional development.
• Access to a company canteen with diverse meal options.
• Discounts on public transportation or affordable parking solutions.