Clinical Trial Manager

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

📋 Description

• Oversee all clinical operational and quality dimensions of assigned studies, ranging from low to moderate complexity, in accordance with ICH GCP standards.

• Create clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in collaboration with the Data Quality Plan.

• Assist in the formulation of the Master Action Plan (MAP) for delivering clinical-related documentation.

• Guarantee timely setup, organization, content, and quality of pertinent sections of the Trial Master File (both local and central).

• Work alongside the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off sessions.

• Partner with the clinical team and other departments as necessary to achieve project deliverables.

• Maintain regular communication with the team and lead meetings to ensure that timelines, resources, interactions, and quality are upheld.

• Accountable for the execution and training of standardized clinical monitoring processes within the study, adhering to corporate standard policies.

• Ensure the prompt archiving of documents and study materials for the department.

• Confirm the attainment of the final clinical deliverable within the agreed contractual timeline by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects via tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.

• Continuously monitor or co-monitor clinical trials to evaluate performance and ensure compliance with contractual obligations.

• May engage with study sites regarding matters such as protocol adherence, patient participation, case report form completion, and other study-related concerns.

• May coordinate all start-up activities and ensure timely ethics committee and regulatory submissions (if applicable) are addressed.

• Ensure that the quality of essential documents aligns with the expectations of Regulatory Compliance Review.

• Review and follow up on any questions raised by ethics committees.

• May contribute to the preparation of forecast estimates for clinical activities.

• Responsible for managing clinical resources, assigning and delegating clinical responsibilities, and identifying additional resource needs.

⛳️ Requirements

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

• Prior experience that equips the individual with the knowledge, skills, and abilities necessary to fulfill the job (approximately 5+ years).

• Strong leadership abilities, effective at mentoring and training, and skilled in motivating and integrating teams.

• Proficient planning and organizational skills to facilitate effective workload prioritization.

• Strong interpersonal and problem-solving capabilities to thrive in a multicultural matrix organization.

• Able to work effectively in an evolving environment with complex or ambiguous situations.

• Familiarity with the practices, processes, and requirements of clinical monitoring.

• Sound judgment and decision-making skills.

• Proficient oral and written communication skills, including proficiency in the English language.

• Capable of assessing workload against project budget and adjusting resources as needed.

• Strong financial acumen and understanding of budgeting, forecasting, and fiscal management.

• Keen attention to detail.

• Solid understanding of relevant regulations, such as ICH/GCP and FDA guidelines.

• Competent computer skills to effectively utilize automated systems and applications like Outlook, Excel, Word, etc.

🏝️ Benefits

• Health insurance.

• Flexible working hours.

• Paid time off.

• Opportunities for professional development.

• Options for remote work.