Bionical Emas

Project Manager

• Support the Project Lead on the delivery of several EAPs, including taking minutes, drafting project documentation, managing supporting stakeholders/affiliates, and assisting with reporting
• Contribute to client meetings lead by Project Lead
• Take ownership of project control for programs
• Be the Patient Access point of contact for programs and support site transitions for post-trial access where required
• Support the project lead to deliver against program specific KPIs to maintain operational excellence
• Coordinate all necessary internal resource to deliver outstanding client experience and service throughout the lifecycle of every program, as directed by the Project lead and/or line manager
• Provide each client with a tailored service for individual requirements to ensure service offerings exceed client expectations
• Support the development of industry leading systems and processes to ensure successful program delivery
• Identify and escalate operational efficiencies and program enhancements to promote continuous improvement
• Ensure quality and regulatory requirements are met and ensure all country specific requirements are followed, promote patient centricity throughout all activity
• Support the business development team with any required activity and support broader EAP activity as required, including marketing and internal projects

Project Coordinator, EAP – East Coast

Data Scientist

• Lead end-to-end management, governance, and quality of real world data (RWD) initiatives, serving as the primary point of contact for all Sponsor deliverables, escalations, and timelines
• Design and implement robust data governance and quality frameworks tailored to Early Access Programs and broader observational research, including risk identification and mitigation
• Ensure consistent mapping, standardisation, and interpretation of real world data elements across geographies, programs, and data sources, including reconciliation of clinical, site-reported, and safety datasets
• Develop and maintain Standard Operating Procedures (SOPs), Work Instructions, and data management documentation covering data design, processing, quality control, coding, transfers, and archiving
• Build and manage studies within the EDC system, overseeing study specification documents including Data Management Plans, Data Validation Plans, and eCRF Completion Guidelines across all study builds and revisions
• Perform ongoing data quality checks, discrepancy management, and issue resolution, while proactively ensuring all program milestones such as data cuts, DBLs, and TFLs are met on time
• Ensure full compliance with applicable global privacy and regulatory requirements including GDPR and HIPAA, maintaining audit-ready documentation and version control across all programs
• Manage medical coding activities using standard terminologies including MedDRA, WHO Drug, SNOMED, ICD-10, and ATC, and deliver well-documented datasets to support HEOR analyses and regulatory evidence packages
• Collaborate cross-functionally with Regulatory, Medical, Compliance, and external vendor teams, supporting sponsor audits, inspections, and RFP processes including bid defence meetings
• Drive continuous improvement through automation, standardisation, and tool optimisation, contributing to the evolution of organisational standards for real world evidence in early and expanded access settings

Project Coordinator, EAP – East Coast

Senior Data Manager, RWE Solutions