# Project Manager FSA - India

**Company**: ICON
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/India-Bangalore/XMLNAME--Sr--Project-Manager--Feasibility-Site-Activation_JR156755?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_21c0f715-c0d

## Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Project Manager – Feasibility & Site Activation, you will play a critical role in driving the successful start-up of global clinical studies.

**Responsibilities**

- Shape and execute Study Start-Up strategies across global, multi-country studies, ensuring alignment with timelines, scope, and sponsor expectations

- Lead the development and delivery of comprehensive Study Start-Up Plans, covering regulatory, ethics, and contract execution across all participating countries

- Drive end-to-end start-up activities from site identification through to IP release, maintaining momentum and accountability for key milestones

- Provide strategic input at Bid Defense and Kick-Off meetings, influencing study design and start-up feasibility from the outset

- Oversee regulatory and ethics submissions, ensuring high-quality, compliant, and timely approvals across regions

- Manage site contract and budget negotiations in collaboration with legal, finance, and sponsors, supporting timely site activation

- Proactively identify risks, dependencies, and bottlenecks, implementing mitigation and escalation strategies to protect study timelines

- Partner closely with Project Managers and cross-functional stakeholders, ensuring seamless integration of start-up within overall study delivery

- Ensure accuracy, quality, and inspection readiness of all study documentation, including oversight of CTMS and eTMF activities

- Lead and coordinate Study Start-Up team members, providing direction, support, and oversight to ensure consistent delivery

- Drive process consistency and continuous improvement across regions, contributing to operational excellence initiatives

- Maintain oversight of study metrics, budgets, and scope of work (SOW), ensuring delivery within agreed parameters

- Provide clear, structured reporting and updates to sponsors and internal leadership, enabling informed decision-making

**Your Profile**

- Proven, recent experience with Study Start-Up (SSU) as a primary responsibility, including end-to-end ownership of site activation activities

- Experience delivering SSU across global or multi-country clinical studies

- Strong knowledge of regulatory and ethics submission processes, including CA/EC and CTA strategy

- Experience coordinating site contracts and budgets within start-up timelines

- Demonstrated ability to manage SSU timelines, risks, and competing priorities

- Hands-on familiarity with CTMS, eTMF, and clinical trial systems

- Solid understanding of ICH-GCP and applicable regulatory frameworks

- Strong stakeholder management and communication skills across sponsors, sites, and internal teams

- Ability to collaborate effectively across cross-functional, global teams

- Structured, proactive, and solution-oriented approach to delivery

**Rewards & Benefits**

- Competitive base salary and performance-related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- CTMS
- eTMF
- clinical trial systems
- ICH-GCP
- regulatory submission processes

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/India-Bangalore/XMLNAME--Sr--Project-Manager--Feasibility-Site-Activation_JR156755?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)