Position: Clinical Data Manager Our organisation is looking for an ambitious Clinical Data Manager 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. Main Accountabilities: Develop SOPs, work instructions, and training materials for clinical operations teams. 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. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Review source data and ensure completeness, accuracy, and regulatory compliance. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Essential Skills and Experience: Strong project management capabilities with experience in agile or structured methodologies. Superior writing and communication skills with experience preparing executive-level documents. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Collaborative, proactive, and able to operate effectively with minimal supervision. 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. 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 A distinguished opportunity awaits a seasoned Clinical Data Manager within our progressive, innovation-led organisation. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Role Responsibilities: Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Review source data and ensure completeness, accuracy, and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Education and Experience Requirements: Proven ability to manage competing priorities in a deadline-driven, dynamic environment. High degree of professionalism, integrity, and alignment with organisational values. Minimum 35 years of progressive professional experience in a comparable role. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Experience collaborating within cross-functional teams and matrix organisational structures. 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 role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Principal Responsibilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. 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. Provide clinical site training on data collection standards and regulatory requirements. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Candidate Requirements: Sound understanding of organisational dynamics and stakeholder management in complex environments. 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. Critical and strategic thinking skills with the ability to translate insights into clear actions. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Recognised qualification in the relevant professional field at the undergraduate or graduate level. 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 Our organisation is looking for an ambitious Clinical Data Manager committed to quality outcomes and sustained growth. This is an opportunity to be part of a purpose-driven team reshaping industry standards and best practices. Primary Duties and Responsibilities: Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Provide clinical site training on data collection standards and regulatory requirements. 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. Develop SOPs, work instructions, and training materials for clinical operations teams. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Review source data and ensure completeness, accuracy, and regulatory compliance. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Required Qualifications: Strong interpersonal and stakeholder management skills with a client-service orientation. Commitment to ongoing professional learning and industry knowledge enhancement. Proficiency in relevant software and digital tools specific to the functional area. Ability to work both independently and in a team-oriented, collaborative environment. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. 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 Data Manager We invite a proactive and capable Clinical Data Manager to lead and execute within a collaborative, agile environment. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Key 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. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. 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. 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. Qualifications and Requirements: Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Experience collaborating within cross-functional teams and matrix organisational structures. Minimum 35 years of progressive professional experience in a comparable role. Excellent verbal and written communication skills; fluency in English is essential. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.

Position: Clinical Data Manager A distinguished opportunity awaits a seasoned Clinical Data Manager within our progressive, innovation-led organisation. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Key Deliverables and Responsibilities: Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. 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. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Professional Requirements: Demonstrated teamwork skills and the ability to build trust and rapport across functions. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. 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. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Strong communication, presentation, and interpersonal skills across all organisational levels. 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 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. Principal Responsibilities: Provide clinical site training on data collection standards and regulatory requirements. 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. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Develop SOPs, work instructions, and training materials for clinical operations teams. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Candidate Requirements: 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. Critical and strategic thinking skills with the ability to translate insights into clear actions. Sound understanding of organisational dynamics and stakeholder management in complex environments. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Effective presentation skills with the ability to communicate complex ideas with clarity. 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 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. Key Responsibilities: Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. 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. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Qualifications and Requirements: A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Excellent verbal and written communication skills; fluency in English is essential. High degree of professionalism, integrity, and alignment with organisational values. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. 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 A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Scope of Responsibilities: Conduct structured literature reviews and contribute to scientific summaries and labelling. 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. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. 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. Participate in regulatory inspections, health authority meetings, and internal audits. Support collection and review of adverse event safety data from clinical and post-market sources. Competencies and Qualifications: Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Ability to work both independently and in a team-oriented, collaborative environment. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.

Position: Clinical Data Manager We are looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Responsibilities Include: Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. 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. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Ensure all cases are coded and processed per MedDRA and applicable global standards. Conduct structured literature reviews and contribute to scientific summaries and labelling. Skills and Qualifications: Hands-on experience with tools, software, and platforms standard to the profession. Strong communication, presentation, and interpersonal skills across all organisational levels. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Willingness to travel, adapt, and take on additional responsibilities as the business demands. 26 years of relevant industry experience with evidence of increasing responsibility. A structured, results-driven approach with the ability to meet defined milestones consistently. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.