Bridges preclinical research and clinical development through translational science. Develops biomarker strategies for patient selection and response prediction. Designs companion diagnostic development programs for oncology and rare diseases. Conducts PK/PD analyses integrating preclinical and clinical data. Supports proof-of-concept clinical study designs with mechanistic endpoints. Manages biomarker sample collection and analysis in clinical trials. Collaborates with discovery, development, and clinical teams across programs. Prepares translational strategy documents for regulatory and scientific review. Contributes to clinical protocol design with scientific and mechanistic perspectives. Presents translational science at internal decision-making and governance forums. Manages CRO and academic collaborations for translational research programs. Supports IND and CTA filings with preclinical and translational data packages. Stays current with precision medicine, biomarker science, and companion diagnostics.

Manages day-to-day manufacturing operations for oral solid dosage forms or injectables. Oversees production planning, scheduling, and adherence to production targets. Ensures GMP compliance across all production activities and areas. Reviews and approves batch manufacturing records and deviation reports. Leads investigation of production failures, deviations, and OOS results. Manages manufacturing team performance, training, and development activities. Coordinates with QA, QC, planning, engineering, and procurement teams. Oversees validation and qualification activities for equipment and processes. Monitors production KPIs and identifies opportunities for efficiency improvement. Prepares capacity utilization reports and production budget management. Manages interactions with regulatory authority inspection teams during audits. Ensures 5S, EHS, and housekeeping standards are maintained consistently. Stays current with GMP regulations, FDA warning letters, and industry best practices.

Assists surgical teams in operating theatre procedures and setups. Performs scrub and circulating nurse duties during surgical cases. Ensures surgical instruments, drapes, and equipment are prepared. Manages surgical counts for instruments, swabs, and needles. Maintains sterile field and aseptic technique throughout procedures. Assists anaesthesiologist with patient positioning and airway management. Documents intraoperative care and implant usage records. Coordinates patient transport to and from operating theatre. Manages surgical supply inventory and instrument tracking systems. Reports equipment faults and ensures timely maintenance response. Participates in surgical safety checklists and WHO protocols. Ensures compliance with CSSD sterilization and disinfection standards. Trains junior OT nursing staff and student nurses.

Position: Clinical Data Manager Our firm seeks a competent and professional Clinical Data Manager for a critical role in a high-performance environment. This is an excellent opportunity for professionals who value structured career advancement and meaningful impact. Primary Duties and Responsibilities: Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Provide clinical site training on data collection standards and regulatory requirements. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Required Qualifications: Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Proficiency in relevant software and digital tools specific to the functional area. At least 24 years of hands-on experience in a comparable professional setting. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We look forward to welcoming a driven professional who shares our commitment to excellence and sustained impact.

Position: Associate Clinical Research Associate - Oncology - NJ/NY Our firm seeks a competent and professional Associate Clinical Research Associate - Oncology - NJ/NY for a critical role in a high-performance environment. 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. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Develop SOPs, work instructions, and training materials for clinical operations teams. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Professional Requirements: Bachelor's or master's degree in a related discipline with strong academic and professional credentials. A structured, results-driven approach with the ability to meet defined milestones consistently. Willingness to travel, adapt, and take on additional responsibilities as the business demands. Strong communication, presentation, and interpersonal skills across all organisational levels. Hands-on experience with tools, software, and platforms standard to the profession. 26 years of relevant industry experience with evidence of increasing responsibility. 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.