Website:
beyondborderconsultants.com
Job details:
A leading employer in the pharmaceutical, biotechnology and contract research organization (CRO) sector delivering end-to-end clinical development and site management services across India. We run Phase I–IV studies and investigator-initiated projects with a strong focus on regulatory compliance, patient safety and timely delivery of clinical milestones.
Primary role title: Clinical Operations Manager (On-site, India)
Role & Responsibilities
- Lead and execute day-to-day clinical operations for assigned studies across India — manage site selection, activation, monitoring, and close-out activities.
- Coordinate cross-functional teams (clinical monitoring, safety, data management, regulatory) to meet timelines, milestones and budget targets.
- Oversee vendor and CRO performance: manage contracts/SOWs, track deliverables, and drive corrective actions to meet quality standards.
- Ensure ICH-GCP and local regulatory compliance; maintain inspection-ready trial documentation and own eTMF completeness.
- Design and implement patient recruitment and retention strategies in collaboration with sites to optimize enrollment.
- Define and monitor operational KPIs, risk-mitigation plans and deliver actionable study status reports to stakeholders.
Skills & Qualifications Must-Have
- Clinical trial management
- ICH-GCP
- CTMS
- eTMF
- Safety reporting
- Site monitoring
Preferred
- Vendor management
- Regulatory submissions
- Risk-based monitoring (RBM)
Qualifications & Experience
- Bachelor's degree in life sciences, pharmacy, nursing or related field.
- Proven clinical operations experience in India with exposure to site management, CRO oversight and regulatory processes.
- Willingness to travel regularly to clinical sites across India.
Benefits & Culture Highlights
- On-site role with frequent field engagement and direct impact on study delivery across India.
- Opportunity to lead pivotal studies and influence operational best practices in a high-growth clinical research environment.
- Supportive team culture with focus on professional development and regulatory-quality excellence.
Skills: regulatory submissions,operations,management,milestones,vendor management,clinical operations
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