Position: Senior Manager, Clinical Data Standards An exceptional opportunity has arisen for a talented Senior Manager, Clinical Data Standards to contribute to our mission. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Scope of Responsibilities: 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. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Conduct structured literature reviews and contribute to scientific summaries and labelling. 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. Ensure all cases are coded and processed per MedDRA and applicable global standards. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Competencies and Qualifications: Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. At least 24 years of hands-on experience in a comparable professional setting. Ability to work both independently and in a team-oriented, collaborative environment. Strong interpersonal and stakeholder management skills with a client-service orientation. 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. 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: Clinical Data Manager We are currently recruiting a results-oriented Clinical Data Manager to strengthen our high-performing team. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Role Responsibilities: Provide clinical site training on data collection standards and regulatory requirements. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Develop SOPs, work instructions, and training materials for clinical operations teams. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Review source data and ensure completeness, accuracy, and regulatory compliance. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Education and Experience Requirements: Minimum 35 years of progressive professional experience in a comparable role. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. 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. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. 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 organisation invites applications from accomplished professionals for the role of Clinical Data Manager. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Principal Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. 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. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Candidate Requirements: 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Sound understanding of organisational dynamics and stakeholder management in complex environments. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Critical and strategic thinking skills with the ability to translate insights into clear actions. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Advanced competency in analytical tools, reporting platforms, and role-specific technology. 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: Clinical Data Manager An exciting career opportunity exists for a motivated Clinical Data Manager to advance their professional journey. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Key Deliverables and Responsibilities: Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Provide clinical site training on data collection standards and regulatory requirements. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Professional Requirements: Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Demonstrated teamwork skills and the ability to build trust and rapport across functions. Strong communication, presentation, and interpersonal skills across all organisational levels. Willingness to travel, adapt, and take on additional responsibilities as the business demands. 26 years of relevant industry experience with evidence of increasing responsibility. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. 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: Clinical Data Manager We seek a dedicated and solutions-focused Clinical Data Manager to join our cross-functional, high-performing team. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Duties and Accountabilities: 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. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Support collection and review of adverse event safety data from clinical and post-market sources. 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. Conduct structured literature reviews and contribute to scientific summaries and labelling. Key Skills and Qualifications: Commitment to professional ethics, confidentiality, and the highest standards of conduct. Sound understanding of organisational dynamics and stakeholder management in complex environments. Effective presentation skills with the ability to communicate complex ideas with clarity. Advanced competency in analytical tools, reporting platforms, and role-specific technology. 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. 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 Supply Chain Manager Ancillary Management Our organisation is looking for an ambitious Clinical Supply Chain Manager Ancillary Management committed to quality outcomes and sustained growth. This is an excellent opportunity for professionals who value structured career advancement and meaningful impact. Main Accountabilities: Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Develop SOPs, work instructions, and training materials for clinical operations teams. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Essential Skills and Experience: 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. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Collaborative, proactive, and able to operate effectively with minimal supervision. Superior writing and communication skills with experience preparing executive-level documents. 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 Manager We invite a proactive and capable Clinical Data Manager to lead and execute within a collaborative, agile environment. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Scope of Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Conduct structured literature reviews and contribute to scientific summaries and labelling. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. 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. 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. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Competencies and Qualifications: Commitment to ongoing professional learning and industry knowledge enhancement. Ability to work both independently and in a team-oriented, collaborative environment. Strong interpersonal and stakeholder management skills with a client-service orientation. Detail-oriented mindset with the ability to synthesise and present complex information clearly. At least 24 years of hands-on experience in a comparable professional setting. 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. Successful candidates will receive access to ongoing professional development and industry-leading resources.

Position: Clinical Data Management - Program Manager We are expanding our team and seek a driven Clinical Data Management - Program Manager who brings expertise, initiative, and professionalism. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Responsibilities Include: Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Participate in regulatory inspections, health authority meetings, and internal audits. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Conduct structured literature reviews and contribute to scientific summaries and labelling. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Support collection and review of adverse event safety data from clinical and post-market sources. Skills and Qualifications: 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. A structured, results-driven approach with the ability to meet defined milestones consistently. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. 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: Clinical Data Manager We are looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Core Responsibilities: Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. 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. Support collection and review of adverse event safety data from clinical and post-market sources. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Minimum Qualifications: 4+ years of experience with a demonstrated track record of growth and professional impact. Strong project management capabilities with experience in agile or structured methodologies. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Superior writing and communication skills with experience preparing executive-level documents. 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 Data Manager Join our forward-thinking team as a Clinical Data Manager and play a pivotal role in our continued success. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Primary Duties and Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Provide clinical site training on data collection standards and regulatory requirements. Review source data and ensure completeness, accuracy, and regulatory compliance. Required Qualifications: Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. 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. Commitment to ongoing professional learning and industry knowledge enhancement. 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. 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.