Senior Project Manager, Feasibility Site Activation

🕒 July 29

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 24%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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 participating countries • Drive end‑to‑end start‑up activities from site identification through to IP release • Provide strategic input at Bid Defense and Kick‑Off meetings • Oversee regulatory and ethics submissions across regions • Manage site contract and budget negotiations with legal, finance, and sponsors • Identify risks, dependencies, and bottlenecks, implementing mitigation and escalation strategies • Partner with Project Managers and cross‑functional stakeholders • Ensure accuracy, quality, and inspection readiness of study documentation, including CTMS and eTMF activities • Lead and coordinate Study Start‑Up team members • Drive process consistency and continuous improvement across regions • Maintain oversight of study metrics, budgets, and scope of work • Provide structured reporting and updates to sponsors and internal leadership

🎯 Requirements

• 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 • Legal right to work in the country where the role is based

🏖️ 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

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