Clinical Trial Manager-Quality

Cinical Trial Manager - Quality Assurance- South Korea

You will play a vital client facing line management role, embedded in our clients business. You will be responsible for the management of day to day clinical trial quality activities, ensuring everyone is well-trained on ICON standard processes, and promoting efficiency, quality, and timeliness in project work.

You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:

• Provides advice to Local Study Teams on company procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations.
• Provides competent advice on local regulations related to clinical trials, keeps abreast of changes in local regulations related to clinical trials and keeps local teams and local processes updated.
• Ownership of local procedural framework.
• Supports local management in the planning and conduct of local quality control activities as described in the local annual quality plan, including performing accompanied site visits. Performs any required QC visits / QC activities with local staff and maintains the annual quality plan updated.
• Provides local management with information regarding status of quality observed in the local clinical team.
• Collaborates with and supports local study teams to resolve quality and compliance issues.
• Reviews regularly Protocol Deviations and ensures Quality Issues are reported within the appropriate timelines to local Authorities and in company internal review systems according to company QI process.
• Supports the local organisation in the preparation for, conduct of and responses to audits and regulatory inspections.
• Advises Local Study Teams on the resolution of the findings in audit and inspection reports. Gives regular feedback on audit and inspection findings to relevant clinical research staff.
• Shares learnings from local audits and inspections with local staff and with regional  clinical quality network, shares global/regional learnings with local staff.
• Identifies and ensures resolution of potential risks based on previous study/systems QC results, audit and inspection results and current routine quality management work.
• Is a key contact in the evaluation and management of fraud/poor quality cases, communicating with Quality Assurance (QA), and local management, as required.
• Identifies and organises/provides on-going and ad hoc training of local staff according to local training needs, in cooperation with local clinical research leadership

#LI-remote

#LI-SO1

You are:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification
• At least 5 years of experience in the pharmaceutical industry, preferably in Development Operations/Quality Assurance
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Good understanding of the drug development process and related GXP activities.
• Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring.
• Excellent organisational skills.
• Excellent verbal and written communication skills.
• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

#LI-SO1

#LI-Remote