Job Requirements:
The Clinical Operations Lead will be responsible for the end-to-end execution of Pandorum’s early clinical studies, ensuring protocol fidelity, high-quality data generation, and operational rigor. This role requires strong leadership in managing global clinical trials across India, the U.S., and Europe, with a focus on early-phase studies, biologics, and advanced therapeutics. The individual will drive cross-functional alignment, regulatory compliance, and timely delivery of key clinical milestones.
Key Responsibilities
- Plan and execute early clinical pilots and investigator-led studies.'
- Develop and manage study timelines, budgets, and operational plans to ensure timely delivery.
- Lead site initiation, training, monitoring, and close-out.
- Ensure SOP-compliant imaging, biomarker sampling, and assessments.
- Coordinate PIs, site coordinators, CROs, and vendors.
- Monitor enrollment, deviations, and timelines.
- Maintain trial master files and documentation.
- Proactively identify operational and study-level risks and implement mitigation plans.
- Ensure delivery of high-quality, reliable, and audit-ready clinical data.
- Provide regular updates to leadership on study progress, risks, timelines, and key milestones.
- Work closely with the CMO and Biostatistics Lead.
Required Qualifications
- Master’s degree in Life Sciences, Medicine, Pharmacy, or a related field.
- 15+ years of clinical operations experience, with strong exposure to early-phase clinical trials.
- Proven experience managing global, multi-site clinical trials across India, the U.S., and Europe.
- Experience working with CDSCO, USFDA, EMA regulatory frameworks.
- Strong knowledge of GCP and clinical trial logistics.
Job Location : Delhi
Preferred Attributes
-Ophthalmology or rare disease trial experience.
-Ability to operate in lean organizations.
-Strong organizational and communication skills.
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