유명 바이오 제약회사에서 다음과 같이 'CQM (Clinical Quality Management)'를 찾고 있습니다.
* Position: CQM (Clinical Quality Management)
* Department: Clinical Operation Frontiers
* Location: Songdo

[RESPONSIBILITIES]
- The Clinical Operation Frontiers group is aiming to become global experts on biosimilar products’ clinical studies by developing and executing operational strategies and FMEA (Failure Mode and Effect Analysis) that are specialized for biosimilar product clinical development through the growth of people, operational quality and expediency. The Clinical Operation Frontiers group is also striving to ensure excellent quality of data being generated through robust clinical data management and quality control processes that meet the relevant regulatory requirements to gain market authorization.
- Ensure that quality of project conduct is being controlled/managed in accordance with the ICH GCP, relevant regulations and laws, protocol and applicable SOPs throughout the clinical project.

1. Provide professional quality management to projects and manage CRO as quality manager
2. Act as an audit liaison manager in case of audit at investigator site audit or CRO system audit, if required
3. Perform quality control activities such as on-site QC visit, data QC, document QC (on e-TMF, Sponsor TMF file) and related functions, to ensure high quality of data/documents and relevant project deliverables
4. Develop SOPs, Manual, Guidelines and training programs for Clinical Operation Frontier group in relation to quality control activities.
5. Lead and establish quality control team and maintain sound working relationships and effective communication within the clinical team and with other business area

[QUALIFICATIONS]
- Bachelor’s degree or above (Major: Pharmacy, Nursing, Medical Science preferred)
- Over 10 years experiences in clinical research industry
- Minimum 6 years clinical project management or quality management experiences in pharmaceutical companies
- Minimum 3 years clinical research associate experiences
- Comprehensive technical and business knowledge in order to perform quality management roles for clinical studies
- In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Excellent communication and interpersonal skills, including good command of English language
- Ability to balance operational and strategic priorities
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
- Sound judgment, decision making and problem solving skills
- Competent written and verbal communication skills.
- Efficient time management and prioritization
- Able to take initiative and work independently

Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently  Only qualified candidates will be contacted for interview  All resumes not contacted will be kept in DB confidentially for future positions

Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com