Manages clinical trial supply chain including IMP manufacturing and labeling. Plans and manages demand forecasting for investigational medicinal products. Coordinates IMP manufacturing at CMOs and internal production sites. Manages IMP labeling, packaging, and randomization for blinded studies. Oversees cold chain distribution of IMP to global clinical trial sites. Manages drug accountability records and depot inventory worldwide. Coordinates IMP returns, destruction, and reconciliation at study close-out. Ensures compliance with IMP regulations under EU CT Directive and ICH GCP. Manages comparator sourcing and regulatory status for controlled trials. Prepares clinical supply agreements with CMOs and service providers. Coordinates with clinical operations for site activation and supply timelines. Manages import and export permits for IMP across global study countries. Stays current with CTMS, IMP regulations, and clinical supply chain technologies.

Designs statistical analysis plans for Phase I, II, and III clinical trials. Performs statistical analysis of clinical trial data using SAS or R software. Prepares statistical outputs including tables, figures, and listings (TFLs). Reviews and validates clinical data for statistical consistency and accuracy. Supports sample size calculations and randomization schedules for trials. Contributes statistical sections to clinical study reports and regulatory submissions. Collaborates with data management teams on database lock and data review. Provides statistical input for protocol design and study feasibility assessments. Develops statistical specifications for programming and validation activities. Reviews and approves SAS programs used for regulatory submission outputs. Supports adaptive trial design and interim analysis planning. Provides biostatistical training and guidance to junior statisticians. Stays updated with FDA statistical guidelines, ICH E9 R1, and estimand framework.

Performs diagnostic laboratory tests in haematology, biochemistry, and microbiology. Operates and maintains laboratory equipment and analyzers. Collects blood, urine, and other biological specimens from patients. Processes samples and ensures proper handling and storage procedures. Performs quality control and calibration of laboratory instruments. Reports critical values to clinicians promptly and accurately. Maintains laboratory records, reagent inventory, and consumable stocks. Ensures NABL compliance and laboratory accreditation standards. Handles hazardous biological materials following biosafety protocols. Troubleshoots laboratory equipment technical issues and errors. Participates in proficiency testing and external quality assurance programs. Trains junior laboratory staff and student technicians. Prepares daily laboratory workload and TAT performance reports.

Position: Clinical Education Specialist, Structural Intervention - NYC/New Jersey A dynamic organisation seeks an experienced Clinical Education Specialist, Structural Intervention - NYC/New Jersey to take on a multifaceted and impactful role. This is an opportunity to be part of a purpose-driven team reshaping industry standards and best practices. Key Deliverables and Responsibilities: Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Develop SOPs, work instructions, and training materials for clinical operations teams. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Professional Requirements: Strong communication, presentation, and interpersonal skills across all organisational levels. Willingness to travel, adapt, and take on additional responsibilities as the business demands. Hands-on experience with tools, software, and platforms standard to the profession. A structured, results-driven approach with the ability to meet defined milestones consistently. 26 years of relevant industry experience with evidence of increasing responsibility. Demonstrated teamwork skills and the ability to build trust and rapport across functions. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We value talent and invest in our people this role offers both professional challenge and meaningful rewards.

Position: Principal Clinical Data Engineer We are expanding our team and seek a driven Principal Clinical Data Engineer who brings expertise, initiative, and professionalism. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Core Responsibilities: Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Support collection and review of adverse event safety data from clinical and post-market sources. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Ensure all cases are coded and processed per MedDRA and applicable global standards. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Minimum Qualifications: Collaborative, proactive, and able to operate effectively with minimal supervision. Strong project management capabilities with experience in agile or structured methodologies. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. 4+ years of experience with a demonstrated track record of growth and professional impact. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Superior writing and communication skills with experience preparing executive-level documents. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This position represents a unique platform for a high-calibre professional to make a lasting contribution.