Senior Clinical Trial Manager – Sr CTM

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

📋 Description

• Oversee all clinical and start-up operations, including the operational and quality dimensions of assigned studies that vary in complexity from moderate to high, ensuring compliance with ICH GCP standards.

• Serve as the main point of contact for start-up activities and site activation within the designated region and/or on a global scale, driving timelines and ensuring excellence in operations.

• Create start-up and clinical tools (such as Essential Document Checklist, Monitoring Plan, Monitoring Guidelines) in alignment with study requirements and the Data Quality Plan.

• Partner with the project manager to prepare, organize, and deliver presentations at client meetings, which include bid defense and hand-off sessions.

• Maintain regular communication with the team and facilitate team meetings to ensure adherence to timelines, resource management, interactions, and quality standards.

⛳️ Requirements

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification.

• Prior experience that equips you with the necessary knowledge, skills, and abilities to excel in this role (approximately 5+ years).

• Extensive experience managing the complete clinical trial start-up (SSU) process, especially within the APAC region.

• Proven ability to lead cross-functional collaboration with CAS, RAL, ICF PM, GCS, Contract Management, and other stakeholders for effective study execution.

• Strong leadership capabilities, adept at mentoring and training, and able to inspire and unify teams.

• Excellent planning and organizational skills to prioritize personal and team workloads effectively.

• Exceptional interpersonal and problem-solving abilities to thrive in a multicultural matrix organization.

• Solid grasp of change management principles.

• Thorough understanding of the processes, practices, and requirements related to start-up and clinical monitoring.

• Strong judgment, decision-making, escalation, and risk management competencies.

• Proficient oral and written communication skills, with a strong command of the English language.

• Capable of assessing personal and team workloads against the project budget and reallocating resources as needed.

• Strong financial understanding, including budgeting, forecasting, and fiscal management.

• Meticulous attention to detail.

• In-depth knowledge of relevant regulations, such as ICH/GCP and FDA guidelines.

• Proficient in using automated systems and computer applications like Outlook, Excel, Word, etc.

• Capable of independently managing clinical-only studies.

🏝️ Benefits

• Opportunities for continued career advancement.

• Award-winning training programs.

• Benefits that prioritize the health and wellbeing of our employees.