Position Overview: We are seeking an experienced Clinical Trial Regulatory and Operations Manager based in Delhi/NCR/ Mumbai/ Bengaluru/ Hyderabad who will ensure the timely initiation and successful execution of clinical trials. The ideal candidate will have extensive knowledge of India's clinical trial regulatory landscape, CDSCO submissions, import licensing, and operational oversight of clinical research activities. This position reports directly to the Managing Partner. Key Responsibilities: Manage end-to-end regulatory submission processes including preparation and submission of Clinical Trial Applications (Form CT-04) and Import License Applications (Form CT-16 & CT-17). Ensure product labeling and documentation fully comply with NDCT Rules (2019) and other CDSCO requirements. Coordinate with CDSCO, Ethics Committees, and clinical sites to achieve timely approvals and clearances. Oversee CRO activities, ensuring alignment with project timelines and regulatory compliance, including handling of tripartite agreements if necessary. Lead operational planning, site initiation visits, and investigator training programs. Monitor import logistics, inventory management, and ensure compliance with investigational product handling guidelines. Conduct regular cross-functional meetings and status reviews, proactively addressing issues and mitigating potential delays. Global Regulatory Submissions: Need to have experience in preparation and submission of comprehensive regulatory dossiers/ GCT for the US FDA, CDSCO (India). Qualifications: Bachelor's degree required; advanced degree preferred in Life Sciences, Pharmacy, or related fields. Minimum 10 plus years of experience in clinical trial regulatory affairs and operations in India. Strong experience with CDSCO submissions, IMPD/CMC dossier preparation, ethics committee coordination, and investigational drug importation. Previous exposure to complex biologics or antibody-drug conjugates is strongly preferred. Excellent project management, problem-solving, and interpersonal skills. Proficient in English and Hindi, with strong written and verbal communication abilities. Show more Show less

We are seeking an experienced Clinical Trial Regulatory and Operations Manager based in Delhi/NCR who will ensure the timely initiation and successful execution of clinical trials. The ideal candidate will have extensive knowledge of India's clinical trial regulatory landscape, CDSCO submissions, import licensing, and operational oversight of clinical research activities. This position reports directly to the Managing Partner. Key Responsibilities: Manage end-to-end regulatory submission processes including preparation and submission of Clinical Trial Applications (Form CT-04) and Import License Applications (Form CT-16 & CT-17). Ensure product labeling and documentation fully comply with NDCT Rules (2019) and other CDSCO requirements. Coordinate with CDSCO, Ethics Committees, and clinical sites to achieve timely approvals and clearances. Oversee CRO activities, ensuring alignment with project timelines and regulatory compliance, including handling of tripartite agreements if necessary. Lead operational planning, site initiation visits, and investigator training programs. Monitor import logistics, inventory management, and ensure compliance with investigational product handling guidelines. Conduct regular cross-functional meetings and status reviews, proactively addressing issues and mitigating potential delays. Qualifications: Bachelor's degree required; advanced degree preferred in Life Sciences, Pharmacy, or related fields. Minimum 10 plus years of experience in clinical trial regulatory affairs and operations in India. Strong experience with CDSCO submissions, IMPD/CMC dossier preparation, ethics committee coordination, and investigational drug importation. Previous exposure to complex biologics or antibody-drug conjugates is strongly preferred. Excellent project management, problem-solving, and interpersonal skills. Proficient in English and Hindi, with strong written and verbal communication abilities Show more Show less

Job Title: Clinical Trial Manager Company Overview: We/eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research environments across India. Position Summary: We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations. Key Responsibilities: Lead clinical operations and site-level engagement for assigned Phase’s studies in India Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness Coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines Conduct ongoing risk assessment and drive mitigation strategies across sites Provide oversight to field CRAs and monitor site compliance Contribute to internal SOP development and quality initiatives Key Qualifications: Bachelor’s degree in life sciences or related field; advanced degree preferred Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers Strong working knowledge of GCP, ICH, and CDSCO guidelines Proven track record managing multi-site studies and remote monitoring teams Excellent interpersonal, communication, and problem-solving skills Proficiency in CTMS, EDC, and eTMF systems is a plus Willingness to travel across India as needed (up to 25%) Show more Show less

We are seeking an experienced Clinical Trial Regulatory and Operations Manager based in Delhi/NCR who will ensure the timely initiation and successful execution of clinical trials. The ideal candidate will have extensive knowledge of India's clinical trial regulatory landscape, CDSCO submissions, import licensing, and operational oversight of clinical research activities. This position reports directly to the Managing Partner. Key Responsibilities: Manage end-to-end regulatory submission processes including preparation and submission of Clinical Trial Applications (Form CT-04) and Import License Applications (Form CT-16 & CT-17). Ensure product labeling and documentation fully comply with NDCT Rules (2019) and other CDSCO requirements. Coordinate with CDSCO, Ethics Committees, and clinical sites to achieve timely approvals and clearances. Oversee CRO activities, ensuring alignment with project timelines and regulatory compliance, including handling of tripartite agreements if necessary. Lead operational planning, site initiation visits, and investigator training programs. Monitor import logistics, inventory management, and ensure compliance with investigational product handling guidelines. Conduct regular cross-functional meetings and status reviews, proactively addressing issues and mitigating potential delays. Qualifications: Bachelor's degree required; advanced degree preferred in Life Sciences, Pharmacy, or related fields. Minimum 10 plus years of experience in clinical trial regulatory affairs and operations in India. Strong experience with CDSCO submissions, IMPD/CMC dossier preparation, ethics committee coordination, and investigational drug importation. Previous exposure to complex biologics or antibody-drug conjugates is strongly preferred. Excellent project management, problem-solving, and interpersonal skills. Proficient in English and Hindi, with strong written and verbal communication abilities Seniority Level Mid-Senior level Industry Biotechnology Research Show more Show less

Company Overview: We/eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research environments across India. Position Summary: We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations. Key Responsibilities: Lead clinical operations and site-level engagement for assigned Phase’s studies in India Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness Coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines Conduct ongoing risk assessment and drive mitigation strategies across sites Provide oversight to field CRAs and monitor site compliance Contribute to internal SOP development and quality initiatives Key Qualifications: Bachelor’s degree in life sciences or related field; advanced degree preferred Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers Strong working knowledge of GCP, ICH, and CDSCO guidelines Proven track record managing multi-site studies and remote monitoring teams Excellent interpersonal, communication, and problem-solving skills Proficiency in CTMS, EDC, and eTMF systems is a plus Willingness to travel across India as needed (up to 25%)

Job Title: Clinical Trial Manager Company Overview: We eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research environments across India. Position Summary: We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations. Key Responsibilities: Lead clinical operations and site-level engagement for assigned Phase’s studies in India Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness Coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines Conduct ongoing risk assessment and drive mitigation strategies across sites Provide oversight to field CRAs and monitor site compliance Contribute to internal SOP development and quality initiatives Key Qualifications: Bachelor’s degree in life sciences or related field; advanced degree preferred Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers Strong working knowledge of GCP, ICH, and CDSCO guidelines Proven track record managing multi-site studies and remote monitoring teams Excellent interpersonal, communication, and problem-solving skills Proficiency in CTMS, EDC, and eTMF systems is a plus

Job Title: Clinical Trial Manager Company Overview: We eteraflex connects a fast-growing global CRO specializing in oncology, rare diseases, and immunotherapies. Our mission is to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research environments across India. Position Summary: We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations. Key Responsibilities: Lead clinical operations and site-level engagement for assigned Phase’s studies in India Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness Coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines Conduct ongoing risk assessment and drive mitigation strategies across sites Provide oversight to field CRAs and monitor site compliance Contribute to internal SOP development and quality initiatives Key Qualifications: Bachelor’s degree in life sciences or related field; advanced degree preferred Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers Strong working knowledge of GCP, ICH, and CDSCO guidelines Proven track record managing multi-site studies and remote monitoring teams Excellent interpersonal, communication, and problem-solving skills Proficiency in CTMS, EDC, and eTMF systems is a plus