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Clinical Data Manager

QuartesianClinicalResearchPvt

Bangalore, Mumbai

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager We invite a proactive and capable Clinical Data Manager to lead and execute within a collaborative, agile environment. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Responsibilities Include: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Conduct structured literature reviews and contribute to scientific summaries and labelling. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. 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. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Participate in regulatory inspections, health authority meetings, and internal audits. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Skills and Qualifications: Strong communication, presentation, and interpersonal skills across all organisational levels. A structured, results-driven approach with the ability to meet defined milestones consistently. Hands-on experience with tools, software, and platforms standard to the profession. 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. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. 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.

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Clinical Data Manager

Quanticate

Chennai, Delhi

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager We are expanding our team and seek a driven Clinical Data Manager who brings expertise, initiative, and professionalism. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Core Responsibilities: Participate in regulatory inspections, health authority meetings, and internal audits. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. 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. 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. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Minimum Qualifications: Collaborative, proactive, and able to operate effectively with minimal supervision. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. 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. Superior writing and communication skills with experience preparing executive-level documents. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We offer a competitive remuneration package commensurate with experience and market standards. Qualified candidates are encouraged to apply.

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Clinical Data Manager

PPD

Mumbai, Bangalore

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager An exceptional opportunity has arisen for a talented Clinical Data Manager to contribute to our mission. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Duties and Accountabilities: 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. 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. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Participate in regulatory inspections, health authority meetings, and internal audits. Key Skills and Qualifications: Commitment to professional ethics, confidentiality, and the highest standards of conduct. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Advanced competency in analytical tools, reporting platforms, and role-specific technology. 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. Critical and strategic thinking skills with the ability to translate insights into clear actions. 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.

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Clinical Data Manager

Pfizer

Bangalore, Hyderabad

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Scope of Responsibilities: Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Support collection and review of adverse event safety data from clinical and post-market sources. 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. Participate in regulatory inspections, health authority meetings, and internal audits. 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: 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. 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. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. 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.

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Clinical Data Manager

Novotech

Delhi, Mumbai

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

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. Key Deliverables and Responsibilities: Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Develop SOPs, work instructions, and training materials for clinical operations teams. 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. Provide clinical site training on data collection standards and regulatory requirements. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Professional Requirements: Hands-on experience with tools, software, and platforms standard to the profession. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. A structured, results-driven approach with the ability to meet defined milestones consistently. 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. 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.

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Clinical Data Manager

MaxHealthcare

Chennai, Pune

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

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. Main Accountabilities: Conduct benefit-risk assessments and contribute to clinical development strategy discussions. 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. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Review source data and ensure completeness, accuracy, and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Essential Skills and Experience: Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Strong project management capabilities with experience in agile or structured methodologies. 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. 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.

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Clinical Data Manager

Indegene

Mumbai, Bangalore

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager We are expanding our team and seek a driven Clinical Data Manager who brings expertise, initiative, and professionalism. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Key Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. 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. Conduct structured literature reviews and contribute to scientific summaries and labelling. Ensure all cases are coded and processed per MedDRA and applicable global standards. 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. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Qualifications and Requirements: 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. Minimum 35 years of progressive professional experience in a comparable role. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Excellent verbal and written communication skills; fluency in English is essential. 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.

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Clinical Data Manager

HCLTechnologiesLtd

Delhi, Hyderabad

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

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. Duties and Accountabilities: Support collection and review of adverse event safety data from clinical and post-market sources. Participate in regulatory inspections, health authority meetings, and internal audits. Ensure all cases are coded and processed per MedDRA and applicable global standards. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Conduct structured literature reviews and contribute to scientific summaries and labelling. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Key Skills and Qualifications: 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. 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. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Sound understanding of organisational dynamics and stakeholder management in complex environments. 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.

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Clinical Data Manager

GVK

Bangalore, Delhi

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager We invite a proactive and capable Clinical Data Manager to lead and execute within a collaborative, agile environment. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Scope of Responsibilities: 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. Participate in regulatory inspections, health authority meetings, and internal audits. Conduct structured literature reviews and contribute to scientific summaries and labelling. 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. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Competencies and Qualifications: Commitment to ongoing professional learning and industry knowledge enhancement. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. 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. 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. This is an outstanding opportunity for a motivated professional to advance their career within a reputable organisation.

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Clinical Data Manager

Glenmark

Chennai, Mumbai

·

3 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

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: 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. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. 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. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Provide clinical site training on data collection standards and regulatory requirements. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Required Qualifications: 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. 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. 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.