R&D Clinical Trial Support Manager (Clinical Operations)

Location: Hyderabad, India

Company

hirify.global develops medicines and healthcare solutions focused on improving patient outcomes and advancing science.

What you will do

• Support clinical study leaders with study execution, delivery, risk identification, contingency planning, issue escalation, and study-plan monitoring.
• Develop, review, maintain, and archive study documents and operational materials in accordance with SOPs and Trial Master File requirements.
• Support study budget preparation, quarterly forecasting, expenditure and accrual tracking, vendor reconciliation, and invoice approval.
• Organize study team, country lead, investigator, monitoring, and vendor meetings, and support training activities.
• Coordinate clinical sample management, including collection, receipt, analysis, tracking, reconciliation, and issue resolution with laboratories and clinical teams.
• Support investigational medicinal product validation, shipment, resupply, reconciliation, audit preparation, and pre-approval inspection readiness.

Requirements

• Bachelor’s degree required; an advanced or scientific degree is preferred.
• 6–8 years of experience in clinical operations and clinical study management.
• Knowledge of clinical development, GCP, ICH guidelines, FDA and EMA regulations, and SOPs/QDs.
• Experience collaborating with clinical study leaders, cross-functional teams, vendors, and external partners.
• Strong organizational, prioritization, problem-solving, communication, and autonomous working skills.
• Fluent English required for negotiations, international meetings, meeting minutes, emails, study documents, and internal and external communications.

Culture & Benefits

• Equal-opportunity workplace welcoming people from diverse backgrounds.
• Work focused on better medications, outcomes, and scientific progress.