Clinical Operations

• Develop evaluation frameworks and rubrics for AI agents operating in clinical operations and global development contexts
• Define quality dimensions for specialized outputs, e.g. clinical data queries, anomaly detection, protocol Q&A responses, ICF content, regulatory documents
• Design and run human evaluation protocols with clinical, regulatory, and site-facing subject matter experts
• Build benchmark datasets and evaluation pipelines that the broader GenAI organization uses across AI applications
• Partner with our AI engineering teams to translate evaluation findings into measurable improvement
• Contribute to the methodology of how a regulated pharma organization evaluates AI in clinical work

Post Doctoral Researcher, Evaluation & Standards, Clinical Operations

• Provide strong, independent leadership for assigned clinical projects, ensuring successful execution.
• Serve as the primary point of contact for clients, vendors, and internal stakeholders.
• Oversee study management activities, including site selection, initiation, monitoring, and closeout.
• Develop and maintain study timelines, budgets, and project plans, ensuring adherence to scope.
• Mitigate risks and proactively address challenges to keep projects on track.
• Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs.
• Manage vendor relationships and study-specific contracts.
• Provide mentorship and guidance to junior project team members.
• Support proposal development, bid defense meetings, and business growth initiatives.
• Participate in internal and external project team meetings to ensure alignment and success.

Clinical Project Manager – Renal

• Lead country-level planning and execution of clinical trials, including site selection, initiation, monitoring, and close-out, ensuring recruitment and retention targets are met.
• Manage regulatory and ethics submissions, ensuring compliance with ICH-GCP, local regulations, and sponsor requirements, and tracking approvals and amendments.
• Oversee sites, CRAs, and local vendors, resolving operational issues and escalating risks when necessary.
• Control country budgets and resources, support contract negotiations, and ensure financial accuracy and timely invoicing.
• Ensure quality and audit readiness through regular checks, supporting inspections, and implementing CAPAs.
• Act as the main local contact for global stakeholders, providing progress updates, risk mitigation plans, and maintaining accurate clinical documentation and reporting.

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Post Doctoral Researcher, Evaluation & Standards, Clinical Operations

Clinical Project Manager – Renal

Local Clinical Project Manager