Clinical Trial Management Expertise

15 hours ago

Vellore, Tamil Nadu, India beBeeClinicalResearch Full time ₹ 60,00,000 - ₹ 1,00,00,000
Senior Research Operations Specialist

We are seeking an experienced Senior Research Operations Specialist to lead the execution of Phase I, II and III oncology studies at key national institutions in India.

The successful candidate will drive site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations. Key responsibilities include:

  • Leading clinical operations and site-level engagement for assigned Phase's studies in India
  • Managing relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals
  • 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
  • Collaborating with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness
  • Coordinating regulatory submissions and ethics committee (EC) approvals; ensuring alignment with CDSCO, ICMR, and local EC timelines
  • Conducting ongoing risk assessment and driving mitigation strategies across sites
  • Providing oversight to field CRAs and monitoring site compliance
  • Contributing to internal SOP development and quality initiatives

Key qualifications for this role include:

  • 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

This role plays a pivotal part in driving our mission to accelerate access to innovative treatments by combining regulatory precision with deep site engagement, particularly in complex government-led research environments across India.

We offer a dynamic and collaborative work environment, with opportunities for growth and professional development. If you have a strong desire to make a difference in clinical research, we encourage you to apply.

Benefits:

  • A competitive compensation package
  • Opportunities for professional growth and development
  • A collaborative and dynamic work environment

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