Position: Entry Level Provider Contract/Cost of Care Analyst Health Economics A distinguished opportunity awaits a seasoned Entry Level Provider Contract/Cost of Care Analyst Health Economics within our progressive, innovation-led organisation. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Role Responsibilities: Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Review source data and ensure completeness, accuracy, and regulatory compliance. Provide clinical site training on data collection standards and regulatory requirements. Education and Experience Requirements: High degree of professionalism, integrity, and alignment with organisational values. Experience collaborating within cross-functional teams and matrix organisational structures. Strong analytical and problem-solving skills with the ability to navigate complex challenges. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Excellent verbal and written communication skills; fluency in English is essential. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Applications are reviewed on a rolling basis; suitably qualified individuals are encouraged to apply promptly.

Position: Associate Clinical Research Associate - Oncology - NJ/NY An exceptional opportunity has arisen for a talented Associate Clinical Research Associate - Oncology - NJ/NY to contribute to our mission. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Key Responsibilities: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Ensure all cases are coded and processed per MedDRA and applicable global standards. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Support collection and review of adverse event safety data from clinical and post-market sources. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Qualifications and Requirements: Minimum 35 years of progressive professional experience in a comparable role. High degree of professionalism, integrity, and alignment with organisational values. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. Strong analytical and problem-solving skills with the ability to navigate complex challenges. 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.

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: Clinical Research Manager We are on the lookout for a well-rounded Clinical Research Manager to contribute to our operational and strategic priorities. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Scope of Responsibilities: Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Support collection and review of adverse event safety data from clinical and post-market sources. Conduct structured literature reviews and contribute to scientific summaries and labelling. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. 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. Ensure all cases are coded and processed per MedDRA and applicable global standards. Competencies and Qualifications: Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Ability to work both independently and in a team-oriented, collaborative environment. At least 24 years of hands-on experience in a comparable professional setting. Strong interpersonal and stakeholder management skills with a client-service orientation. Commitment to ongoing professional learning and industry knowledge enhancement. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This is an outstanding opportunity for a motivated professional to advance their career within a reputable organisation.

Position: Clinical Research Manager An exciting career opportunity exists for a motivated Clinical Research Manager to advance their professional journey. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Role Responsibilities: Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. 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. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Education and Experience Requirements: Strong analytical and problem-solving skills with the ability to navigate complex challenges. Excellent verbal and written communication skills; fluency in English is essential. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. The organisation provides a comprehensive benefits package and excellent career advancement opportunities for the right candidate.

Position: Sr. Engagement Manager - Medical Affairs Consulting Our organisation is looking for an ambitious Sr. Engagement Manager - Medical Affairs Consulting committed to quality outcomes and sustained growth. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Primary Duties and Responsibilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Provide clinical site training on data collection standards and regulatory requirements. Develop SOPs, work instructions, and training materials for clinical operations teams. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Required Qualifications: Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. 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. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.

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: Clinical Data Standards Programming Manager (ADaM SDTM) An exceptional opportunity has arisen for a talented Clinical Data Standards Programming Manager (ADaM SDTM) to contribute to our mission. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Duties and Accountabilities: Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Conduct structured literature reviews and contribute to scientific summaries and labelling. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Ensure all cases are coded and processed per MedDRA and applicable global standards. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Key Skills and Qualifications: Recognised qualification in the relevant professional field at the undergraduate or graduate level. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Sound understanding of organisational dynamics and stakeholder management in complex environments. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We are committed to fostering an inclusive workplace and welcome applications from candidates of all backgrounds.

Position: Manager, Clinical Trial Disclosure Group (CTDG) We are currently recruiting a results-oriented Manager, Clinical Trial Disclosure Group (CTDG) to strengthen our high-performing team. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Main Accountabilities: Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Review source data and ensure completeness, accuracy, and regulatory compliance. Essential Skills and Experience: Superior writing and communication skills with experience preparing executive-level documents. 4+ years of experience with a demonstrated track record of growth and professional impact. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Collaborative, proactive, and able to operate effectively with minimal supervision. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.

Position: Project Manager I (Clinical Research), Division of General Internal Medicine Our organisation invites applications from accomplished professionals for the role of Project Manager I (Clinical Research), Division of General Internal Medicine. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Role Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Provide clinical site training on data collection standards and regulatory requirements. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. 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. Education and Experience Requirements: A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Minimum 35 years of progressive professional experience in a comparable role. Excellent verbal and written communication skills; fluency in English is essential. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. The organisation provides a comprehensive benefits package and excellent career advancement opportunities for the right candidate.