Site Operations Specialist

19 hours ago

Anantapur, Andhra Pradesh, India beBeeClinicalTrialManager Full time ₹ 20,00,000 - ₹ 25,00,000

Job Title: Clinical Trial Manager

Job Description:

As a seasoned Clinical Trial Manager, you will be responsible for leading the execution of Phase I, II and III oncology studies at key national institutions in India.

This pivotal role requires driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations.

You will 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.

Responsibilities include overseeing timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection.

Ensuring study milestones are met, including First Patient First Visit (FPFV) and clean database targets, is also part of your duties.

Collaboration with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness is essential.

Additionally, you will coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines.

Ongoing risk assessment and driving mitigation strategies across sites are also critical responsibilities.

Providing oversight to field CRAs and monitoring site compliance completes your key tasks.

Required Skills and 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
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

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