Clinical Data Manager

Position Summary

As an integral member of the Clinical Operations team, the Clinical Data Management Specialist supports all Clinical data management functions within timeline and quality objectives, from study start-up through close-out. With oversight from management, this position partners to develop and execute Data Management Plans (DMPs) and builds and validates Electronic Data Capture (EDC). This position requires strong knowledge of EDC experience in clinical trials and related regulations, and the ability to perform at a high level in a fast-paced, dynamic environment.  

Principal Responsibilities

• Review and contribute to the authorship of protocols and other study documentation promoting consistency across and within business unit(s). 

• Develop Electronic eCRFs, program edit/rule checks, query logic and generate database specifications using EDC. 

• Implements CDISC/SDTM standards within eCRFs to ensure compliance and data consistency. 

• Performs additional validation or data processing tasks using SAS programming. 

• Lead the process for study team review of the following: eCRF Screen review(s), Edit/Rule review including EDC database specification process with study team(s). 

• Create User Acceptance test scripts, execution logs for User Acceptance Testing (UAT) and engage the Study team for testing participation. 

• Develop eCRF Completion Guidelines according to study design, promoting quality data. 

• Develop and maintain the Data Management Plan (DMP) throughout the lifecycle of the study, ensuring the DMP is followed according to study design and requirements. 

• Manage in-stream data cleaning, validation, for in-house studies, accounting for Interim Analysis, abstract deliverables, final database locks, while supporting data analysis and reporting. 

• Generate study metric reports related to Query Management, site performance and SDV, but not limited to these activities. 

• Oversee, review, and approve Data Management Plans, CRF Completion Guidelines, external data transfer agreements and other study documentation as applicable. 

• Conduct DMP and EDC training to internal teams and sites and develop and update training manuals. 

• Organize ongoing data review to ensure the highest caliber data, on time, in conjunction with monitoring and data locks. 

• Conducts regular reviews of clinical trial data in conjunction with monitoring teams and ensures compliance with GCP, 21 CFR Part 11, ISO 14155, and MDR requirements. 

Education / Experience Requirements

• Master’s degree preferred (e.g., in medicine, life sciences, natural sciences, mathematics, or computer science); Bachelor’s degree acceptable with relevant experience. 

• Two to three years of professional experience in clinical data management or a closely related field.  

• Proficiency in CDISC/SDTM implementation (is an advantage). 

• Programming knowledge in SAS, with working knowledge of SQL, R, and Python (is an advantage). 

• Experience developing and maintaining data validation plans and documentation. 

• Strong understanding of GCP, ISO 14155, MDR and 21 CFR Part 11 compliance (required) 
• Fluent in written and spoken English, basic proficiency in German is considered as a plus.

What we offer

• Flexible working hours
• Mobile Working up to 40%
• At least 25 days of holidays
• Friday after Ascension is a paid absence day
• Training and further development opportunities
• Company canteen with various options
• Discounts for public transportation or affordable parking options