Senior Project Specialist

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

📋 Description

• Execute study activities such as start-up, maintenance, and close-out under the guidance and oversight of Clinical Operations team members.

• Conduct eTMF functional quality control and oversight quality control for PMS.

• Upload study documents to the Trial Master File or other designated repositories.

• Review and engage in the quality assurance process of data or documents.

• Assist in the creation of documents and standard forms.

• Organize logistics and agendas for study meetings, and help with the minutes.

• Monitor and prepare study-specific information utilizing databases, spreadsheets, and various tools.

• Maintain internal databases, tools, and document repositories for Clinical Operations.

• Provide administrative assistance for study-related tasks under the supervision of Clinical Operations.

• Serve as a local subject matter expert or point of contact for specific focus areas when necessary.

• Collaborate with other departments to accomplish assigned tasks.

• Ensure that all work adheres to established practices, policies, processes, and regulatory standards.

⛳️ Requirements

• At least 1 year of relevant experience in SSU, CTA, or as a Study Coordinator from investigational sites within Pharma/CRO.

• BA / BS / RN degree.

• Familiarity with local country regulations, ICH Guidelines, GCP, and standard clinical operating procedures.

• Preferred experience with eTMF, CTMS, and SSU(A).

• Proficient in basic office programs and tools.

• Excellent verbal and written communication skills in both Korean and English.

• Strong and clear communication abilities.

• Capacity to support a team-oriented and highly matrixed environment.

• Skill to manage multiple assigned tasks efficiently.

• Ability to work proactively with minimal supervision.

• Quick learner with the ability to adapt to new information.

• Flexibility and adaptability to changing circumstances.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive total rewards program.

• An inclusive culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Collaborate with dedicated problem solvers.

• Work within specialized therapeutically or functionally aligned teams.

• Be part of a diverse team of experts.

• Various career paths and employment opportunities available.