Role & responsibilities

1. Early Phase Clinical Study Quotations (Core Responsibility)

- Lead preparation and review of quotations for:
- Phase I clinical Studies
- Early Phase - BA/BE studies (primary focus)

- Analyze study protocols and finalize costing based on:

- Study design (SAD/MAD, fed/fasted, replicate design, etc.)
- Subject population and complexity
- Clinical unit and operational requirements

- Collaborate with Medical / Operation / Project Management / Cross-Functional Teams and BD teams to ensure scientifically and operationally aligned Quotes-proposals.

2. Proposal Preparation Across Services

- Prepare / review / Finalize quotations for:
- Pharmacovigilance (PV) Services
- Nutraceutical studies
- Clinical laboratory projects
- Biosimilars / large molecules studies
- Complex / adaptive Studies , Like Topical , Inhalation etc.
- Standalone CDM, Biostatistics & Medical Writing services

- Ensure consistency and integration across multi-service proposals.

3. Pricing Strategy & Business Development Support

- Provide pricing inputs based on study design, complexity, and resource planning.
- Support BD team in:
- Sponsor discussions
- Budget negotiations
- RFP responses and clarifications

- Ensure pricing competitiveness while maintaining profitability and compliance with company benchmarks.

4. Contract & Commercial Finalization

- Finalize quotations in line with approved protocols and sponsor expectations.
- Prepare and review:
- Project-specific agreements




- Work orders and commercial contracts

- Coordinate with Legal and Finance teams to ensure compliance and execution.

5. RFP, Bid Management & Commercial Documentation

- Lead preparation of:
- Bid grids , Inputs for RFPs & RFIs
- Cost models and summaries
- Annual Rate Contracts (ARC)

- Manage strategic and high-value RFP submissions in collaboration with BD leads.
- Take Management / Finance approvals as per process..

7. Cross-functional Stakeholder Coordination (Critical Responsibility)

- Coordinate with key internal teams for accurate costing inputs:
- Clinical Pharmacology / Early Phase Unit Team screening requirements, dosing, clinical procedures, unit utilization etc.
- Clinical Laboratory Team – PK/PD, safety lab and biomarker costing
- Regulatory Team –regulatory requirements
- Data Management (CDM) Team – EDC setup and data handling requirements
- Biostatistics & Medical Writing Teams – analysis and reporting
- Large Molecules / Biosimilars Team – specialized requirements
- Feasibility Team members / Clinical Operations Team – execution feasibility

- Drive timely inputs and alignment across all stakeholders.

8. Proposal Governance & Database Management

- Maintain a centralized master database of quotations, including:
- Version control
- Pricing benchmarks
- Historical proposals

- Track and report on:

- Turnaround time
- Orderbook
- Pricing trends

- Support management reporting and decision-making.

📌 Executive/Senior Executive - Costing and Proposal (Early Phase Quotes) (Ahmedabad)
🏢 Lambda Therapeutic Research
📍 Ahmedabad