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.