Clinical Trial Manager

5 days ago


Hyderabad, India eteraflex connects Full time

Job Title: Clinical Trial ManagerOnsite - HyderabadCompany 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 IndiaManage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitalsOversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collectionEnsure study milestones are met, including First Patient First Visit (FPFV) and clean database targetsCollaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readinessCoordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelinesConduct ongoing risk assessment and drive mitigation strategies across sitesProvide oversight to field CRAs and monitor site complianceContribute to internal SOP development and quality initiativesKey Qualifications:Bachelor’s degree in life sciences or related field; advanced degree preferredMinimum 6-8 years of clinical research experience with at least 3 years in an independent CTM roleDemonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centersStrong working knowledge of GCP, ICH, and CDSCO guidelinesProven track record managing multi-site studies and remote monitoring teamsExcellent interpersonal, communication, and problem-solving skillsProficiency in CTMS, EDC, and eTMF systems is a plus



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