Senior Clinical Trials Associate

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Coordinate and monitor access for the project team to various systems.

• Maintain project portals and conduct quality checks on documentation.

• Assist in the preparation, management, and shipment of documentation for clinical trials, including Investigator Site Files.

• Oversee version control and quality assessments of project documents.

• Ensure that documents are submitted promptly to the Trial Master File.

• Track essential project information, such as site communications and medical question logs.

• Prepare and distribute meeting minutes for sponsor, project, and internal management meetings.

• Maintain records of site and study personnel.

• Organize project-specific training sessions and track their completion.

• Contribute to the onboarding, coaching, training, and leadership development of Clinical Trial Associates.

• Support ongoing process improvement initiatives.

• Collaborate with Project Managers, CRAs, and cross-functional study teams on various clinical projects.

⛳️ Requirements

• Degree-level qualification or equivalent experience is required.

• A minimum of two years in a related role is necessary.

• Proficiency in English and fluency in the local language of the respective country.

• Strong interpersonal abilities are essential.

• Capability to collaborate effectively across project teams.

• Ability to work independently with minimal supervision while also contributing as a team member.

• Excellent organizational, problem-solving, and multitasking skills are required.

• Exceptional attention to detail and a commitment to high-quality standards.

• Ability to mentor, coach, and assist in the development of colleagues.

• Familiarity with ICH, GCP, and relevant FDA or EU regulatory guidelines is important.

• Strong skills in Microsoft Outlook, Word, Excel, and PowerPoint are necessary.

🏝️ Benefits

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or any other class protected by applicable law.

• A diverse and inclusive workplace culture.

• Supportive and collaborative team dynamics.

• Leadership that is accessible and approachable.

• Opportunities for onboarding, coaching, training, and leadership advancement.