Icon Plc Hiring Clinical Study Start-Up Associate

Icon Plc Hiring Clinical Study Start-Up Associate

About the Company (ICON Plc)

Welcome to ICON Plc, where our people are at the heart of everything we do. As a leading Clinical Research Organization (CRO), we pride ourselves on our diverse teams that enable us to be a better partner to our customers. At ICON, we embrace an ‘Own It’ culture, driven by values of Accountability & Delivery, Collaboration, Partnership, and Integrity. Our mission is to advance and improve patients’ lives through excellence in drug development.

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Position Title: Study Start-Up Associate I

Company Name: ICON Plc

Job ID: JR113487

Job Locations: Bangalore, Chennai, Trivandrum, Bengaluru

Employment Type: Hybrid (Office/Remote)

Job Description

About the Role

At ICON, we believe our people make the difference. As a Study Start-Up Associate, you’ll play a crucial role in preparing physicians at research sites to initiate clinical trials for investigational pharmaceutical and biological products. Join us in a dynamic and supportive environment, working with bright and friendly colleagues, and contribute to shaping an industry.

Responsibilities

1. Critical Document Package (CDP) Completion:
   • Coordinate and facilitate CDP and IP release checklist activities in compliance with guidelines and regulations.
   • Focus on quality, efficiency, and cost containment for a specific region or subdivision within the CDP group.
2. Essential Document Review:
   • Review site-level essential documents, ensuring compliance with ICON SOPs/WIs, Sponsor SOPs, and ICH/GCP guidelines.
   • Maintain site-related data in clinical systems accurately and in a timely manner.
3. Investigational Product Release:
   • Prepare and submit Investigational Product Release Pack.
   • Ensure accuracy and timely completeness of Trial Master File (TMF) documents during start-up.
4. Task Progress Communication:
   • Communicate progress of tasks accurately and in a timely manner.
   • Demonstrate high organization skills in a dynamic environment with shifting priorities.
5. Stakeholder Interaction:
   • Interact successfully with internal stakeholders.
   • Perform tasks in accordance with guidelines, company and sponsor SOPs, project plans, and local regulatory requirements.
6. Contract and Budget Negotiation:
   • Review and negotiate clinical site investigator contracts and budgets.
   • Stay connected with investigative sites, sponsors, and internal personnel regarding contract status.
7. Consultancy and Training:
   • Function as an internal consultant on study budgets.
   • Develop and update training documentation, conduct group training, and mentor new and junior personnel in the SSU department.

What You Need

• A high school diploma or local equivalent.
• Bachelor’s degree preferably in Life Sciences.
• Minimum of 1-3 years’ experience or understanding of clinical study start-up requirements and activities.
• Experience in Clinical Trial operations and meeting regulatory guidelines.
• Proficient project management skills.

Benefits of Working at ICON Plc

Our success depends on the quality of our people. At ICON Plc, we’ve built a culture that rewards high performance and nurtures talent.

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