ㆍResponsible for being the contact for CROs for an assigned study. Participate in global/local task forces and initiatives.

ㆍResponsible for activities of site related study execution of assigned studies / Monitors involving start-up, execution, and close-out. Responsible for the on-time and within budget study execution of assigned projects, including but not limiting to country and site feasibility.

ㆍOversee CROs for clinical development plan, site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide global regulatory and legal requirement expertise.

ㆍEnsure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving global regulations, guidelines and policies. Monitor regulatory reforms and industry trends and provide impact analysis of significant changes affecting conduct of Clinical studies.

ㆍEnsure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation.

[자격요건]

ㆍ 학력 : 대졸 이상 (4년)

ㆍ 경력 : 3~7년 (대리~차장급)

ㆍ 언어 : 영어 (fluent)

ㆍ 특이사항 : 해외 출장 가능 인력(~30%), 국내 및 해외 임상 참여 3년 이상

ㆍ 우대사항 : 관련학과(생명과학, 의/약학, 간호학 등), 안과 질환 치료제 경험자 우대 등등

Skills, Experience, Education and Certifications :

ㆍ Bachelor’s or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred

ㆍSite Monitoring Experience preferred

ㆍLanguage: Fluent in English

ㆍStrong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.

ㆍExcellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.

ㆍDemonstrated proactive and positive team player.

ㆍ Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment, with experience participating global projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases.

ㆍ Drives continuous improvement and simplicity in process and approach and enhances agility.

ㆍ Demonstrated business ethics and integrity.

ㆍ There are overseas business trips for global clinical operation (~30% of a year)