South Korea Senior Clinical Trial Associate (CTA)

A leading South Korean pharmaceutical company are currently looking to hire a Senior Clinical Trial Associate (CTA) to join their dynamic team. This CTA position is an exciting opportunity to join a prestigous global company in the Clinical field.

Job Responsibilities:

• Support the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities.
• Oversee the process, system, and tool landscape that supports the management of outsourced TMFs.
• Promote best documentation practice to line functions and provide guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice:
• Create and/or update SOPs, Working Practices, Guidance Documents, templates, etc. as applicable
• Enforce use of standards and adherence to quality by providing training and support to business functions in cooperation with TMF QC Manager
• Coordinate eDMS Super/Key User community for relevant process area.
• Ensure deliverables comply with HA guidelines, Good Clinical Practices, and internal SOPs.
• May act as Business Administrator in the electronic Document Management System (eDMS), ensuring appropriate user access restriction and accurate and compliant document creation; document lifecycle management in close collaboration with system support and business functions.
• Continuously oversee and identify room for improvement for document management processes of outsourced TMFs.
• Lead improvement and innovation initiatives in a matrix organization.
• Act as Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions:
• Orchestrate business requirements for fully outsourced TMFs across NVS and identify achievable business benefits
• Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected
• Support the design of TMF training concept(s) and training material:
• Provide input to technical teams for TMF migration, conduct migration testing in particular for TMF sections previously outsourced to CROs;
• Plan, prepare and oversee rollout and change management activities (communication and training).
• Compliance of TMF relevant documentation as well as efficiency of related processes:
• Ensure the timely submission and delivery of high quality TMF documentation enabling regulatory compliance and applications for marketing approval.

Skills and Requirements:

• Minimum Bachelor's Degree in Life Science/Healthcare or equivalent.
• Thorough knowledge of clinical Trial Master File process, regulatory requirements, and Good Clinical Practice, in particular for outsourced TMF filing activities.
• At least 5 years in clinical development/clinical operations.
• At least 3 years of working experience with document management systems and excellent understanding of system structures and generic document management functionality.
• Advanced knowledge of clinical documentation and reporting.
• Good understanding of technical processes and PC environment including Microsoft suite of products.
• Knowledge of the national and international data protection legislation.
• Experience with project work or project management in a global, cross-functional, multicultural, and international matrix organisation.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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