Are you passionate about clinical research and looking to make a significant impact in the healthcare industry? ACM, a global leader in Clinical Trials and Study Management, is inviting applications for the role of Clinical Trials Administrator based in Mumbai, India. Join our dynamic team and contribute to groundbreaking studies that enhance patient care worldwide.
Company Introduction
ACM is a trusted name in the clinical research domain, specializing in study management, laboratory testing, and providing integrated solutions to pharmaceutical companies, Contract Research Organizations (CROs), and clinical trial sponsors. With a focus on excellence and innovation, ACM is committed to delivering accurate, timely, and high-quality services that drive meaningful outcomes in clinical research.
Responsibilities in Job
As a Clinical Trials Administrator, you will play a crucial role in the lifecycle of clinical studies, from commencement to close-out. Your responsibilities will include:
- Protocol Management:
- Reviewing Clinical Trial Protocols and assisting with protocol setup.
- Developing key documents such as the Protocol Test Summary (PTS), Global Laboratory Specification Document (GLSD), and Investigator Laboratory Manual.
- Project Coordination:
- Supporting daily project-related activities post-study initiation.
- Coordinating with sponsors, CROs, and alliance laboratories.
- Participating in study conference calls, taking minutes, and summarizing action items.
- Metrics and Reporting:
- Monitoring study metrics and trends through customized reports.
- Managing query resolution and action item follow-ups with clients and sites.
- Document and Binder Management:
- Assisting with study binder preparation and performing quality control reviews.
- Archiving project-related documents as per ICH-GCP Guidelines.
- Data and Site Management:
- Ensuring data quality during the data lock process.
- Managing site lists, including updates and contact modifications.
- System and Logistics Support:
- Setting up projects in the Laboratory Information Management System (LIMS).
- Liaising with logistics for phlebotomy kit assembly and supply.
- Coordinating with laboratories for specimen processing and report turnaround.
- Compliance and Quality Assurance:
- Participating in quality audits and inspections.
- Ensuring adherence to regional regulatory bodies, GCP, GDP, and ICH guidelines.
- Customer and Team Engagement:
- Maintaining a positive study experience for all stakeholders.
- Providing excellent customer service by resolving issues promptly.
Qualification
- Master’s degree in Biochemistry, Microbiology, or Chemistry.
- 1 to 2 years of experience in a similar role within a Central Laboratory or CRO.
Preferred Skills
- Excellent verbal and written communication skills.
- Proficiency in computer applications, relational databases, and reporting tools.
- Strong ability to multitask, prioritize workload, and provide exceptional customer service.
- Critical thinking and problem-solving abilities.
