Manager, Bioanalytical Systems & Digital Enablement

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Role: Manager, Bioanalytical Systems & Digital Enablement

The Manager, Bioanalytical Systems & Digital Enablement is responsible for coordinating global strategy, governance, and administration of bioanalytical laboratory systems and supporting digital platforms in close partnership with stakeholders. This role combines strategic coordination with hands‑on operational execution, ensuring that global laboratory systems (e.g., LIMS, ELN, instrument integration) and operational tools are effectively implemented, utilized, compliant, and continuously optimized.

• Responsible for staff management in accordance with the organization’s policies and applicable laws: interviewing, hiring, training, performance appraisal, rewards, discipline, and problem resolution.
• Responsible for the strategic, governance, and execution of bioanalytical systems and digital platforms.

• Co‑develop the global roadmap for bioanalytical systems and digital platforms with input from site stakeholders and functional partners.
• Establish governance that incorporates local requirements and stakeholder input while promoting standardization, scalability, and compliance across all sites.
• Act as both program lead and execution resource, facilitating alignment and consensus across stakeholders.
• Lead global implementations, upgrades, and migrations with active personal involvement where required and in collaboration with site teams.
• Interface with Celerion support teams and site representatives on implementation and utilization of business systems.
• Support the development and coordination of AI initiatives in partnership with operations and site stakeholders.

• Directly administer and maintain laboratory systems (LIMS, ELN, CDS, and related platforms) as needed, in alignment with site requirements and governance processes.
• Manage user access, roles, and permissions in compliance with data integrity requirements and site leadership.
• Monitor system performance, troubleshoot issues, and resolve support tickets, coordinating with local users and support teams.
• Support and/or perform system configuration, upgrades, patching, and integrations, ensuring stakeholder awareness and input where relevant.
• Oversee instrument integration and data flow between lab systems, working closely with site teams.
• Maintain system documentation and support audit and inspection readiness.

• Ensure end‑to‑end data flow and visibility across the bioanalytical lifecycle in collaboration with system owners and site stakeholders.
• Drive integration across systems and platforms, balancing global standards with local operational needs.
• Identify and implement opportunities for automation and efficiency gains in partnership with users and functional teams.

• Facilitate strong alignment between U.S. and Switzerland laboratories through active stakeholder engagement and shared decision‑making.
• Act as a key connector between IT, Bioanalytical Operations, QA, and other departments.
• Drive global consistency while incorporating local input and constraints.
• Facilitate communication, prioritization, and execution across regions and functions, ensuring transparency in decision processes.

• Promote adoption of AI, automation, and advanced analytics in collaboration with stakeholders and subject‑matter experts.
• Evaluate new technologies and manage vendor relationships incorporating cross‑functional and site feedback into recommendations.
• Drive continuous improvement in system utilization, throughput, and data quality through joint initiatives with operational teams.

• Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements in partnership with QA and system stakeholders.
• Support CSV activities and inspection readiness, working closely with QA and site representatives.
• Support audits and…