Clinical Trial Assistant - 193

We are looking for a detail-oriented and organized Clinical Trial Assistant to support the management of clinical trials from initiation through completion. The ideal candidate will assist in ensuring clinical trials are conducted on time, within budget, and in compliance with regulatory requirements, SOPs, and company standards.

Responsibilities:

• Assist the Clinical team in managing MW's clinical study operations, including vendor management (CROs, central labs, data management, etc.).
• Manage contractual issues, payments, and budget tracking with vendors and clinical sites.
• Oversee ordering and tracking of clinical supplies (study drugs, medical devices, and trial accessories).
• Set up and maintain Trial Master Files (TMF) for ongoing clinical studies, ensuring proper documentation and organization.
• Assist with the preparation of IRB/EC submissions and ensure timely filing of regulatory documents.
• Participate in the in-house monitoring of clinical data entered in eCRFs and assist in resolving queries with vendors and the medical team.
• Assist in the preparation of clinical meetings and training sessions, including logistics and content support.
• Review and analyze clinical data listings and reports to ensure compliance and relevance.
• Collaborate with cross-functional teams, including Medical Affairs, Regulatory Affairs, Finance, Legal, Operations, and Quality Assurance, to ensure seamless trial execution.

Requirements:

• Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred.
• At least 2 years of experience as a Clinical Trial Assistant (CTA) in a similar pharmaceutical or biotech company.
• Strong organizational, communication, and interpersonal skills.
• Ability to work independently and prioritize tasks in a fast-paced environment.
• Strong attention to detail and a willingness to learn new clinical, medical, and scientific concepts.
• Ability to work in a hybrid environment (office, home, and travel as required).
• Proficiency in English (written and spoken).
• Familiarity with clinical trial processes, regulatory requirements, and SOPs is a plus.