ICON plc is a global leader in healthcare intelligence and clinical research. With a commitment to advancing clinical research and providing outsourced services to the pharmaceutical, biotechnology, medical device, and government sectors, ICON helps accelerate the development of life-saving drugs and devices. The company prides itself on its patient-centric approach, ensuring that every project contributes to improving the quality of life and saving lives. ICON’s workforce is its greatest asset, driving its success and growth. This is reflected in the culture of innovation and passion that permeates throughout the organization.
Responsibilities in the Job
As a Site Management Associate (SMA) at ICON, you will be a key member of the Strategic Solutions Division, working closely with one of ICON’s top pharmaceutical sponsors. Your role will involve managing all aspects of clinical study operations from initiation to archiving, ensuring that studies are completed on time, within budget, and meet the required scientific and quality standards.
Key responsibilities include:
- eTMF Upload and System Management: You will be accountable for the upload and management of electronic Trial Master Files (eTMF), ensuring that all documentation is accurate and up-to-date.
- Vendor Management: You will oversee and manage vendors under your responsibility, ensuring that they comply with the study’s requirements and timelines.
- Study Budget Management: You will be responsible for tracking and managing the study budget, ensuring financial resources are used efficiently.
- Preparation for Governance and Financial Review Cycles: You will prepare the necessary materials for governance and financial review cycles, contributing to the smooth operation of the study.
- Risk Identification and Mitigation: Proactively identifying potential risks to the study and implementing measures to mitigate these risks will be an essential part of your role.
Qualifications and Skills
To be successful in this role, you need to have:
- Minimum 3 Years of eTMF Experience: A proven track record in managing eTMF in the clinical research industry is essential for this position.
- Fluency in English: You must be able to communicate confidently and clearly in English, both verbally and in writing.
- Proficiency with MS Teams and Office: You should be comfortable using MS Teams and Office applications, particularly Excel, to manage and track study-related data and documents.
- Based in Bangalore: The position is located in Bangalore, so you should either be based in the city or willing to relocate.
