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Senior Clinical Data Manager

IKS Health

Hyderabad, Pune

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4 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Senior Clinical Data Manager A dynamic organisation seeks an experienced Senior Clinical Data Manager to take on a multifaceted and impactful role. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Key Deliverables and Responsibilities: Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Provide clinical site training on data collection standards and regulatory requirements. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. 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. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. 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. 26 years of relevant industry experience with evidence of increasing responsibility. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Demonstrated teamwork skills and the ability to build trust and rapport across functions. 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. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.

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Senior Clinical Data Manager

FORTREA

Chennai, Mumbai

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4 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Senior Clinical Data Manager We are on the lookout for a well-rounded Senior Clinical Data 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. Duties and Accountabilities: Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. 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. 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. Participate in regulatory inspections, health authority meetings, and internal audits. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Key Skills and Qualifications: 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. Effective presentation skills with the ability to communicate complex ideas with clarity. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Sound understanding of organisational dynamics and stakeholder management in complex environments. 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. This is an outstanding opportunity for a motivated professional to advance their career within a reputable organisation.

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Senior Clinical Data Manager

Tata consultancy services

Delhi, Bangalore

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4 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Senior Clinical Data Manager An exciting career opportunity exists for a motivated Senior Clinical Data Manager to advance their professional journey. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Main Accountabilities: 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. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Essential Skills and Experience: Strong project management capabilities with experience in agile or structured methodologies. 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. Collaborative, proactive, and able to operate effectively with minimal supervision. 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.

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Senior Clinical Data Manager

Novartis

Pune, Hyderabad

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4 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Senior Clinical Data Manager We seek a dedicated and solutions-focused Senior Clinical Data Manager to join our cross-functional, high-performing team. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Scope of Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Participate in regulatory inspections, health authority meetings, and internal audits. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. 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. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Competencies and Qualifications: Strong interpersonal and stakeholder management skills with a client-service orientation. Proficiency in relevant software and digital tools specific to the functional area. Ability to work both independently and in a team-oriented, collaborative environment. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. 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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Senior Clinical Data Manager

LabCorp

Chennai, Mumbai

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4 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Senior Clinical Data Manager Our organisation is looking for an ambitious Senior 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. Role Responsibilities: Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Review source data and ensure completeness, accuracy, and regulatory compliance. Develop SOPs, work instructions, and training materials for clinical operations teams. 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. 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. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Education and Experience Requirements: High degree of professionalism, integrity, and alignment with organisational values. 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. Minimum 35 years of progressive professional experience in a comparable role. Excellent verbal and written communication skills; fluency in English is essential. 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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Senior Clinical Data Manager

GSK

Bangalore, Delhi

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4 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Senior Clinical Data Manager We invite a proactive and capable Senior 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. Responsibilities Include: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. 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. 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. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Conduct structured literature reviews and contribute to scientific summaries and labelling. Skills and Qualifications: Strong communication, presentation, and interpersonal skills across all organisational levels. 26 years of relevant industry experience with evidence of increasing responsibility. 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. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. 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.

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Clinical Research Associate / Sr. CRA - Oncology

Flipkart

Hyderabad, Mumbai

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4 w

·

Full time

·

Healthcare

Minimum

$4,00,000 Per Year

Maximum

$12,00,000 Per Year

Position: Clinical Research Associate / Sr. CRA - Oncology A distinguished opportunity awaits a seasoned Clinical Research Associate / Sr. CRA - Oncology within our progressive, innovation-led organisation. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Principal Responsibilities: 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. Review source data and ensure completeness, accuracy, and regulatory compliance. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Provide clinical site training on data collection standards and regulatory requirements. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Candidate Requirements: Commitment to professional ethics, confidentiality, and the highest standards of conduct. Effective presentation skills with the ability to communicate complex ideas with clarity. Sound understanding of organisational dynamics and stakeholder management in complex environments. 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. 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. Applications are reviewed on a rolling basis; suitably qualified individuals are encouraged to apply promptly.

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Clinical Data Manager

Ephicacy

Pune, Bangalore

·

4 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 candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Core Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Ensure all cases are coded and processed per MedDRA and applicable global standards. Conduct structured literature reviews and contribute to scientific summaries and labelling. Participate in regulatory inspections, health authority meetings, and internal audits. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Support collection and review of adverse event safety data from clinical and post-market sources. Minimum Qualifications: Superior writing and communication skills with experience preparing executive-level documents. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Collaborative, proactive, and able to operate effectively with minimal supervision. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. 4+ years of experience with a demonstrated track record of growth and professional impact. 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

Wipro

Chennai, Mumbai

·

4 w

·

Full time

·

Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

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 SOPs, work instructions, and training materials for clinical operations teams. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Review source data and ensure completeness, accuracy, and regulatory compliance. Provide clinical site training on data collection standards and regulatory requirements. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. 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. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Required Qualifications: Commitment to ongoing professional learning and industry knowledge enhancement. 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. 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. Ability to work both independently and in a team-oriented, collaborative environment. 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.

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Clinical Data Manager

TechMahindraLtd

Delhi, Hyderabad

·

4 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 organisation fosters a culture of continuous learning, development, and shared organisational accountability. Key Responsibilities: Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Participate in regulatory inspections, health authority meetings, and internal audits. Ensure all cases are coded and processed per MedDRA and applicable global standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. 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. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Qualifications and Requirements: 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. Minimum 35 years of progressive professional experience in a comparable role. 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. Successful candidates will receive access to ongoing professional development and industry-leading resources.