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Manager, Bioanalytical Systems & Digital Enablement(m/w/x)
Global strategy and governance for bioanalytical systems and digital platforms at a CRO. 8-12+ years in regulated environments with LIMS/ELN/CDS hands-on experience required. Program lead for global implementations and upgrades.
Requirements
- Bachelor’s degree in IT, Life Sciences, or related field (advanced degree preferred)
- 8–12+ years of experience in bioanalytical, clinical research, or regulated environments
- Laboratory systems (LIMS, ELN, CDS) hands-on experience
- System administration, configuration, and troubleshooting experience
- Experience leading system implementations and digital transformation initiatives
- Deep understanding of GxP compliance, data integrity, and validated systems (CSV)
- Strategic leadership capacity
- Hands-on technical execution role capability
- Experience working across global teams (US and Europe preferred)
- Knowledge of data integration, automation, and AI/ML applications in lab environments
- Strong stakeholder management and cross-functional collaboration skills
Tasks
- Coordinate global strategy for bioanalytical systems and digital platforms
- Establish governance for standardization, scalability, and compliance
- Act as program lead and execution resource
- Lead global implementations, upgrades, and migrations
- Interface with Celerion support teams and site representatives
- Support AI initiative development and coordination
- Administer and maintain laboratory systems (LIMS, ELN, CDS)
- Manage user access, roles, and permissions
- Monitor system performance and resolve support tickets
- Perform system configuration, upgrades, and integrations
- Oversee instrument integration and data flow
- Maintain system documentation and support audit readiness
- Ensure end-to-end data flow across the bioanalytical lifecycle
- Drive integration across systems and platforms
- Identify and implement automation and efficiency opportunities
- Facilitate alignment between US and Switzerland laboratories
- Act as a key connector between IT, Bioanalytical Operations, and QA
- Drive global consistency with local input
- Facilitate communication and execution across regions
- Promote AI, automation, and advanced analytics adoption
- Evaluate new technologies and manage vendor relationships
- Drive continuous improvement in system utilization and data quality
- Ensure compliance with GxP, 21 CFR Part 11, and data integrity
- Support CSV activities and inspection readiness
- Support audits and provide system documentation
- Drive user adoption through training and change management
- Define and implement support models
- Serve as a technical escalation point
- Coordinate with relevant teams for resolution and decision-making
- Interview, hire, and train employees
- Plan, assign, and direct work
- Appraise employee performance
- Reward and discipline employees
- Address complaints and resolve problems
- Develop and coach employees
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- LIMS
- ELN
- CDS
- GxP
- CSV
- AI/ML
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Manager, Bioanalytical Systems & Digital Enablement(m/w/x)
Global strategy and governance for bioanalytical systems and digital platforms at a CRO. 8-12+ years in regulated environments with LIMS/ELN/CDS hands-on experience required. Program lead for global implementations and upgrades.
Requirements
- Bachelor’s degree in IT, Life Sciences, or related field (advanced degree preferred)
- 8–12+ years of experience in bioanalytical, clinical research, or regulated environments
- Laboratory systems (LIMS, ELN, CDS) hands-on experience
- System administration, configuration, and troubleshooting experience
- Experience leading system implementations and digital transformation initiatives
- Deep understanding of GxP compliance, data integrity, and validated systems (CSV)
- Strategic leadership capacity
- Hands-on technical execution role capability
- Experience working across global teams (US and Europe preferred)
- Knowledge of data integration, automation, and AI/ML applications in lab environments
- Strong stakeholder management and cross-functional collaboration skills
Tasks
- Coordinate global strategy for bioanalytical systems and digital platforms
- Establish governance for standardization, scalability, and compliance
- Act as program lead and execution resource
- Lead global implementations, upgrades, and migrations
- Interface with Celerion support teams and site representatives
- Support AI initiative development and coordination
- Administer and maintain laboratory systems (LIMS, ELN, CDS)
- Manage user access, roles, and permissions
- Monitor system performance and resolve support tickets
- Perform system configuration, upgrades, and integrations
- Oversee instrument integration and data flow
- Maintain system documentation and support audit readiness
- Ensure end-to-end data flow across the bioanalytical lifecycle
- Drive integration across systems and platforms
- Identify and implement automation and efficiency opportunities
- Facilitate alignment between US and Switzerland laboratories
- Act as a key connector between IT, Bioanalytical Operations, and QA
- Drive global consistency with local input
- Facilitate communication and execution across regions
- Promote AI, automation, and advanced analytics adoption
- Evaluate new technologies and manage vendor relationships
- Drive continuous improvement in system utilization and data quality
- Ensure compliance with GxP, 21 CFR Part 11, and data integrity
- Support CSV activities and inspection readiness
- Support audits and provide system documentation
- Drive user adoption through training and change management
- Define and implement support models
- Serve as a technical escalation point
- Coordinate with relevant teams for resolution and decision-making
- Interview, hire, and train employees
- Plan, assign, and direct work
- Appraise employee performance
- Reward and discipline employees
- Address complaints and resolve problems
- Develop and coach employees
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- LIMS
- ELN
- CDS
- GxP
- CSV
- AI/ML
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Celerion
Industry
Pharmaceuticals
Description
The company is a leader in early clinical research, combining medical expertise with cutting-edge technology to deliver exceptional results.
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