Trial Data Manager (m/f/d)

About the role

A Trial Data Manager is needed for a 24-month position (with option to extend) in Basel-Landschaft. The role covers end-to-end data management for a designated clinical study, from protocol input and eCRF setup through quality control, database lock and reporting, while also mentoring junior data managers and managing outsourced studies.

Key responsibilities

• Ensure all clinical data management and biometry work complies with internal standards and regulatory requirements, and meet study timelines and milestones
• Lead data management workflows, contribute to protocol design, and set up the electronic Case Report Form (eCRF)
• Write data management documentation such as specifications for external data transfers, data cleaning and validation tools
• Coordinate UAT of data entry screens and cleaning tools, then deploy them to production; supervise data cleaning, query resolution and database lock
• Produce regular study metrics, analytics and progress reports, and present on data topics at CTT, investigator and monitor meetings
• Manage outsourced studies and CRO relationships, and help author SOPs and data management guidance
• Act as DM liaison in cross-functional groups, forecast staffing needs, verify that data managers complete training, and coordinate the annotated CRF (aCRF)
• Perform routine Quality Control checks against protocol, Quality System guidelines and GCP, and cover standard Data Manager tasks on site if no junior DM is allocated

Required profile

• Master's degree (M.Sc.) in Life Sciences, Statistics, Mathematics, Informatics or a closely related field
• At least 5 years of professional experience in clinical research or clinical data management within pharma or biotech
• Thorough knowledge of global clinical trial regulations, especially ICH-GCP
• Exceptional organisational skills and excellent written and spoken English
• Ability to mentor, guide and coordinate other data managers on the study

Required skills

• Solid background in clinical databases, data architecture and flow, data validation procedures and electronic CRF design
• Task management and professional presentation to diverse stakeholders