Position: Clinical Operations Assistant
Company: Parexel
Location: Bengaluru
Qualification: Any Graduate
Experience: Not Required
About Parexel
Parexel is a leading global provider of biopharmaceutical services, dedicated to advancing healthcare through scientific excellence. Our expertise spans clinical research, regulatory consulting, and commercialization services. We collaborate with pharmaceutical and biotechnology companies to drive innovations that improve patient outcomes and global health.
Job Overview
We are excited to invite applications for the position of Clinical Operations Assistant in our Bengaluru office. This entry-level role is integral to supporting our clinical trial operations. As a Clinical Operations Assistant, you will manage Case Report Forms, maintain and update project central files, and assist with various administrative duties. Your role will be crucial in ensuring compliance and quality in our clinical research activities.
Key Responsibilities
1. Project Central Files & Clinical Trial Management Systems Maintenance
- Document Management:
- Track, scan, code, and apply naming conventions to documents.
- Send documents to the relevant Work In Progress (WIP) and Central File (CF) areas as per the Central File Maintenance Plan.
- Archiving:
- File and archive paper documents following the Central File Maintenance Plan (CFMP).
- Document Handling:
- Photocopy, print, distribute, and retrieve documents as needed.
- Quality Checks:
- Maintain basic quality checks to ensure accurate document maintenance.
- System Maintenance:
- Track and maintain the Clinical Trial Management System (CTMS) and study-specific site trackers.
- Compliance Monitoring:
- Monitor system statuses to ensure compliance with reporting obligations and safety information.
2. Support to Local Site Management Team
- Administrative Support:
- Assist with local administrative tasks related to billing.
- Quality Control:
- Provide quality control for central files.
- Document Collection:
- Support document collection, customization, and review for trials in Japan.
- Site Liaison:
- Communicate with sites and investigators to facilitate project execution.
- Project Coordination:
- Collaborate with project management teams on assigned tasks.
Skills and Qualifications
- Language Proficiency: Fluency in Japanese (N2 or N3 level) is essential.
- Industry Experience: Preferred experience in CROs or the Life Sciences industry.
- Problem-Solving Skills: Strong problem-solving abilities with a meticulous approach.
- Professional Interaction: Ability to interact professionally within a client organization.
- Task Management: Skilled in prioritizing tasks and meeting deadlines.
- Analytical Skills: Strong analytical skills with autonomous decision-making capabilities.
- Time Management: Effective management of time to meet various project and departmental goals.
- Communication Skills: Excellent verbal and written communication skills.
- Urgency: Demonstrated sense of urgency in completing tasks and meeting deliverables.
Knowledge and Experience
- Clinical Research: Experience in site management or clinical research, with a solid understanding of clinical trial methodologies.
Education
- Degree: A degree in biological sciences, pharmacy, or other health-related disciplines is preferred. Equivalent nursing qualifications or relevant experience will also be considered.
How to Apply
To apply for the Clinical Operations Assistant position at Parexel, please send your resume and a cover letter to careers@parexel.com. For further details about the role and our company, visit our website.