A leading global biopharmaceutical company is hiring a Trial Delivery Specialist – Clinical Trial Coordination for a fully remote role in India. This position operates under an FSP (Functional Service Provider) model, where professionals act as an embedded extension of the sponsor’s global study team.
This execution-focused role is ideal for professionals with experience in clinical trial operations, study coordination, CRO oversight, eTMF management, and vendor management. The position offers exposure to global clinical trials across all phases and therapeutic areas, with strong career progression opportunities.
🧪 Key Responsibilities
As a Trial Delivery Specialist, you will be responsible for end-to-end clinical study coordination, including:
- Partnering with Global Study Leaders to monitor study progress, risks, timelines, budgets, and quality metrics
- Supporting end-to-end study delivery from study start-up to close-out and archival
- Maintaining internal clinical trial systems, databases, trackers, and project plans
- Reviewing key clinical documents such as protocols and informed consent forms (ICF)
- Supporting development of:
- Monitoring plans
- Vendor management plans
- Protocol deviation management plans
- Risk management plans
- Coordinating cross-functional study team communication and meetings
- Acting as a primary point of contact for country oversight, tracking:
- Patient recruitment
- Data completeness and compliance
- Local budgets
- Protocol deviations
- Import license status
Vendor & CRO Oversight
- Managing CROs and third-party vendors
- Tracking study deliverables and resolving operational issues
Clinical Supplies Management
- Overseeing delivery of investigational products (IP) and study materials
- Identifying risks to supply continuity and recommending mitigation actions
eTMF & Inspection Readiness
- Ensuring eTMF setup, completeness, and quality
- Conducting periodic reviews and follow-ups on missing documents
- Managing safety report dissemination and inspection readiness
Budget & Financial Oversight
- Managing change orders, expenses, and financial tracking
- Ensuring alignment between systems and agreements
- Escalating financial risks to stakeholders
🎓 Qualifications & Experience
Preferred qualifications include:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Clinical Research, or related field
- Experience in clinical trial coordination, study operations, or trial delivery
- Strong knowledge of:
- Global clinical trial processes
- eTMF management and inspection readiness
- CRO and vendor oversight
- Excellent communication, stakeholder management, and project coordination skills
- Ability to work in a global, remote, cross-functional environment
💼 Why Join This Role?
- 🌍 Global Exposure: Work on international clinical trials across phases and therapeutic areas
- 🔁 End-to-End Ownership: Involvement from study set-up to close-out
- 📊 Skill Development: Enhance project management, financial oversight, risk management, and analytics
- 🚀 Career Growth: Progress into Study Operations, Project Management, or CRA tracks
- 🤖 Technology-Driven: Exposure to AI-enabled platforms in global clinical trial delivery
💰 Salary & Employment Details
- Salary Range: ₹10,00,000 – ₹18,00,000 per annum (INR)
- Job Type: Full-time
- Work Mode: Fully Remote (India)
- Shift: Second Shift (Afternoons)
📝 How to Apply
