Job Title: Group Leader — Clinical Operations
Location: Hyderabad (Shamirpet)
Employment Type: Full Time
Experience: 5-8 years
About the Role
As a Group Leader — Clinical Operations, you will partner with cross-functional teams to deliver measurable impact within the Vanta Bioscience ecosystem. This role blends hands-on execution with strategic team leadership. You will be responsible for overseeing the planning, execution, and delivery of clinical pharmacology studies (including BA/BE and Phase I trials). Leading a team of Clinical Research Associates (CRAs) and Clinical Project Coordinators, you will ensure that all clinical operations are conducted in strict accordance with GCP, protocol requirements, and regulatory standards, while driving operational efficiency and subject safety.
Responsibilities
- Team Leadership & Mentorship: Lead, manage, and mentor a team of clinical operations professionals. Set performance goals, conduct appraisals, and foster a culture of continuous learning and high performance.
- Clinical Trial Execution: Oversee the end-to-end execution of clinical studies, from site selection and initiation through to monitoring, closure, and final reporting.
- Protocol & Site Management: Review and contribute to the development of clinical study protocols. Ensure clinical sites are adequately trained, equipped, and compliant with the protocol and GCP standards.
- Regulatory & Ethical Compliance: Ensure all clinical activities comply with ICH-GCP guidelines, FDA/EMA/CDSCO regulations, and institutional review board (IRB)/ethics committee requirements.
- Cross-functional Collaboration: Act as the primary clinical operations liaison between Clinical, Bioanalytical, Quality Assurance (QA), Data Management, and Pharmacovigilance teams to ensure seamless study conduct.
- Risk Management & Safety: Proactively identify operational risks and implement mitigation strategies. Ensure strict adherence to subject safety protocols, adverse event (AE) reporting, and pharmacovigilance processes.
- Resource & Budget Management: Assist in forecasting, allocating, and managing clinical operation resources and budgets to ensure timely and cost-effective study delivery.
- Vendor Management: Oversee external vendors and clinical service providers (e.g., central labs, EDC providers, ambulance services) to ensure deliverables meet quality and timeline expectations.
Requirements
- Education: M.Pharm, Pharm.D, MBBS, or M.Sc. in Life Sciences/related field.
- Experience: 5 to 8 years of relevant experience in clinical operations, specifically within a CRO, pharmaceutical, or biotech environment. Experience with BA/BE (Bioavailability/Bioequivalence) or Phase 1 clinical studies is highly preferred.
- Leadership Skills: Minimum of 2 years of experience leading or supervising a team. Proven ability to inspire, mentor, and manage the workload of clinical operations staff.
- Regulatory Knowledge: Deep understanding of ICH-GCP guidelines, CDSCO regulations, and FDA/EMA clinical trial requirements.
- Operational Expertise: Strong background in site management, clinical monitoring, IRB submissions, and informed consent processes.
- Communication & Problem-Solving: Excellent written and verbal communication skills with a proven ability to resolve complex clinical issues and communicate effectively with sites, sponsors, and internal stakeholders.
- Travel: Willingness to travel occasionally for site visits, audits, and sponsor meetings as required.
Benefits
At Vanta Bioscience, we invest in our people because they are the foundation of our scientific and operational excellence. We offer a comprehensive benefits package designed to support your professional growth and personal well-being:
- Health & Wellness: Comprehensive medical, dental, and vision insurance coverage for you and your dependents.
- Financial Security: Competitive salary commensurate with experience, employer-provided life and accidental insurance, and retirement savings/provident fund benefits.
- Work-Life Balance: Generous paid time off (PTO), company holidays, and supportive leave policies.
- Career Growth: Structured career development pathways, access to GCP/clinical training programs, and opportunities to attend industry conferences.
- Work Environment: A collaborative, state-of-the-art clinical facility in Shamirpet designed to foster innovation, teamwork, and operational efficiency.
- Commuter Support: Transportation assistance/facilities for easy commute to the Shamirpet campus.
Interested candidates are encouraged to apply and become a part of our mission to advance clinical research and drug development.