Director, Clinical Operations at Catalyst Clinical Research

, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

25 Dec, 25

Salary

0.0

Posted On

26 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Drug Development Process, MFDS Regulations, ICH GCP Guidelines, Team Leadership, Communication Skills, Presentation Skills, Organizational Skills, Problem-Solving Skills, Analytical Skills, Project Management, Interpersonal Skills, Decision Making, Flexibility, Creativity, Client Relationship Management, Financial Management

Industry

Research Services

Description

Associate Director, Clinical Operations As the Director, Clinical Operations you will be a key member of the Oncology Operations Team. You will be responsible for operational delivery of the studies and/or programs across the Asia Pacific team. You will contribute towards development of the methodology for conduct of the clinical trials, improving current methodology, and being accountable assigned to him/her. Position Responsibilities/Accountabilities: Accountable for the activities of the Asia Pacific team members. May perform some or all PM responsibilities on key projects or as needed to support direct reports and/or clients. Support project activities leading to building client relationships for defines customers and/or contracts; deliver “The Catalyst impact.” Provide input into development of the planning and reporting framework based on and utilizing the core systems, internal KPIs and in line with external customer expectations. Review KPIs tracked per project to monitor overall project delivery and client satisfaction and to take a proactive approach in management engagement and awareness of the project status. Develop SOPs to govern the Asia Pacific function. Identify the need and support development of the Project specific SOPs. Accountable for the financial management of the projects. Responsible for the financial management of the Asia Pacific function. Provide input into development of the departmental budget. Take part in the development and implementation of the revenue recognition, project profitability, contract scope management and invoicing methodologies. Represent Asia Pacific function during QA audits. Accountable for overall project and Asia Pacific team members readiness for the QA audits. Complete CAPA in response to internally identified system/process weaknesses and/or customer complaints related to Clinical Operations. Support to Business Development representatives for the “solutioneering” of appropriate solutions for customers individual needs and the closing and contracting of new business Drive operational elements of proposals and Bid Defense materials in collaboration with other team members. Other responsibilities and ad hoc projects as required. Managerial Requirements/ Responsibilities: Position will have management responsibilities. Development, oversight, and direction of country and departmental staff which will include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting & salary. Position Qualification Requirements: Education: University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology. Master’s Degree in scientific or business discipline preferred. Experience: 10+ years in a clinical research setting with a progression of increased responsibility over time. 2+ years of management experience in a CRO setting with in depth knowledge of the project management activities. Previous exposure to and experience of Oncology specific clinical development complexities. Required Certifications: N/A Required Skills: Strong knowledge of the drug development process and MFDS regulations, ICH GCP guidelines, and their application to clinical trials. Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes. Proficient with Microsoft Office Suite. Excellent written and oral communication skills. Excellent presentation skills. Strong organizational, problem-solving, and analytical skills. Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities. Proven ability to handle multiple projects and meet deadlines. Strong interpersonal skills. Ability to deal effectively with a diversity of individuals at all organizational levels. Commitment to excellence and high standards. Creative, flexible, and innovative team player. Ability to work independently and as a member of various teams and committees. Good judgement with the ability to make timely and sound decisions. Ability and willingness to travel to investigator meetings, investigate sites and bid defense meetings, etc Applicants must be authorized to work for ANY employer in South Korea. We are unable to sponsor or take over sponsorship of an employment visa.

Responsibilities

The Director of Clinical Operations will oversee the operational delivery of studies across the Asia Pacific team and contribute to the development and improvement of clinical trial methodologies. This role includes managing team activities, financial management, and ensuring readiness for QA audits.