ACM Global Laboratories

Project Manager

• Liaise with ACM Global Central Laboratory clients
• Represent ACM as the client's primary point of contact
• Manage from 10 to 25 protocols
• Review clinical protocols and assist with protocol set-up functions
• Conducts investigator training sessions

Clinical Trials Project Manager

Full-stack Engineer

• The Software Engineer - STARLIMS is responsible for performing configuration, customization, and maintenance tasks within the STARLIMS system to support laboratory operations.
• Work collaboratively with business analysts, testers, and client end-users to understand system requirements and implement optimal solutions.
• Develop, configure, and customize established STARLIMS workflows, reports, and dashboards based on documented requirements.
• Assist in analysis, coding, testing and validation efforts for new features, bug fixes, and system upgrades/patches.
• Perform routine maintenance and operational support for STARLIMS and related integration incidents (Break/Fix), escalating complex issues to senior engineers.
• Execute pre-defined code changes and update custom scripts under supervision.
• Support STARLIMS upgrades/patching to ensure functional compliance.
• Manage the utilization / management of STARLIMS services / API, including the development of custom scripts.
• Collaborate with end-users and senior team members to clarify requirements and test solutions.
• Maintain and update technical documentation (configuration guides, test scripts) using tools like JIRA.
• Assist in data migration and data cleanup activities during system updates.
• Follow and adhere to defined application development standards, best practices, and IT Security principles.
• Support the setup and testing of basic interfaces using standards like HL7, JSON, APIs, others with 3rd party systems and Instruments / instrument middleware.
• Develop and maintain sample/workflow management modules, reporting and dashboard components, Stability management, inventory, and instrument management modules.
• Customize business rules, forms, calculations, and user interfaces.
• Troubleshoot system issues and provide tier-2/3 technical support.
• Perform upgrades, patches, hotfix deployments, and version migrations.
• Improve system performance, stability, and security.
• Create / assist in the development and maintain technical design documents, SOPs, configuration specs, and release notes.
• Support validation activities, IQ/OQ/PQ documentation, test scripts and execution, change control processes.

Software Engineer

Compliance

• Lead IT compliance initiatives ensuring adherence to world-wide regulatory authorities, GLP, GCP, and other applicable regulations and standards (e.g., 21 CFR Part 11, 820, Annex 11, OECD 22).
• Manage and execute validation of cloud-based and hosted applications, including risk assessments, validation planning, IQ/OQ/PQ testing, and traceability documentation.
• Primary owner of the system development lifecycle and CSV process and policies and procedures for such.
• Oversee the new system implementation process and IT change management process.
• Develop, review, and maintain key compliance and SDLC documents such as validation protocols, test scripts, SOPs, configuration management, change control, and system release documentation.
• Prepare and lead IT-related activities for FDA, UK, EU and other regulatory inspections or audits; provide expert responses to auditor queries; manage quality events, corrective and preventive actions (CAPAs) resulting from inspections.
• Author and maintain IT compliance policies, procedures, and standard operating procedures (SOPs) to ensure consistent, regulatory-aligned practices across systems and teams.
• Partner with IT infrastructure, cybersecurity, QA, and business system owners to ensure alignment of compliance and validation activities with business needs.
• Evaluate and enhance IT validation and compliance processes for efficiency and scalability in support of digital transformation and cloud adoption.
• Take Quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for the projects that include new implementation, enhancements, quarterly releases, periodic reviews, review and approve Quality events (deviations & CAPS), etc.
• Participate and drive system assessments, review and approve the project deliverables, including plan, test scripts, execution and its outcome, reports, and traceability.
• Actively participate in and guide discussions to resolution, adhering to all quality standards.

Clinical Trials Project Manager

Software Engineer

IT Technical Regulatory Compliance Principal