Clinical Project Manager
Fyte
Localização do trabalho
Taipei
Status de emprego
Tempo total
Detalhes sobre a oferta de trabalho
Description:
We are seeking a highly skilled Clinical Project Manager with exceptional English communication skills to oversee and manage clinical trial operations. As the Clinical Project Manager, you will be responsible for the efficient planning, implementation, and execution of clinical studies in compliance with applicable regulations and ICH GCP guidelines, while adhering to predetermined timelines and budgets. Reporting directly to the Clinical Operations Director, you will play a vital role in ensuring the successful completion of clinical trials.
Responsibilities:
• Develop comprehensive plans and execute all aspects of clinical trials.
• Create and manage budgets, closely monitoring costs throughout the trial process.
• Oversee and coordinate activities with CROs and other vendors to ensure timely achievement of trial milestones.
• Provide regular progress updates on clinical trials to internal project teams and stakeholders.
• Proactively identify and address challenges or quality issues that may arise during trial execution.
• Foster strong relationships and maintain frequent communication with investigators and study staff.
• Conduct co-monitoring visits at clinical sites as required.
• Perform thorough clinical data reviews, including tables, figures, and listings.
• Assist in the review of AEs/SAEs and annual safety reports.
• Participate in the review of Clinical Study Reports.
• Provide clinical trial expertise to support other departments and line functions.
• Contribute to the development and upkeep of work instructions for the clinical operations department.
Requirements
• Master's degree or equivalent in the life sciences. At least 3 years working experience in all operational aspects of planning and executing clinical studies with 2 years project management experience.
• Motivated self-starter and discipline to work independently with minimal guidance.
• Excellent communication and interpersonal skills and strong negotiation and presentation skills.
• Proficiency in written and spoken English and Mandarin.
• Ability to travel and work flexible hours
