Clinical Science Manager
About the role
Clinical Science Manager- Office based- 1 year Fixed Term Contract - South Korea
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:
The CSM is responsible for all appropriate clinical science aspects of the study.
1. Accountability for ensuring the quality of clinical science aspects of clinical trial s to be conducted in patients
- Development of clinical synopsis/clinical protocol (Note: limited to the first health authority approval version in the first country)
- Clinical Science Data review
- Development of clinical study report
- Preparation of modules 2.2. and 2.5 of a common technical document (CTD) (Note: except for CTDs for genetic drugs)
- Preparation of relevant publications
2. Provide input to other study documents
3. Responsibility for the clinical science review of trial data
4. Communicate with appropriate internal and external functions to conduct the review and will report the results of the ongoing science review regularly to the study team
5. Any other duties of clinical science aspects assigned by the CSD
- 시험계획서 작성 및 관련 업무 Coordination
- 임상시험 중 data monitoring (eCRF data review 경험자 선호)
- 결과보고시 작성 및 관련 업무 Coordination
- 과제상황에 따라 학회 발표 자료개발 (slide deck development for poster/oral presentation 또는 manuscript)
- Minimum bachelor's degree in medical science, pharmacy, life sciences, related discipline, or equivalent combination of education and experience
- Significant demonstrable experience (e.g. minimum of 2 years ) in the scientific aspects of clinical development gained within a contract research organization, pharmaceutical/biotechnology company, academic or health authorities
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.
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