호주 시드니에 본사를 두고 있는 Novotech은 아시아 태평양 지역에서 국제적인 명성을 얻고 있는 Full-Service Contract Research Organization (CRO) 입니다. Novotech은 아시아 태평양 지역 대부분의 국가에서 수백 건의 Phase I-IV 글로벌 임상시험을 성공적으로 진행하고 있으며, 모든 임상시험 단계 및 치료분야 전반에서 우수한 서비스를 제공하고 있습니다. 또한 F&S 라는 국제 유수의 기관에서 The Best Biotech Asia-Pacific CRO Award를 수상한 바 있습니다. Novotech은 특히 초기 임상시험과 항암제 임상시험의 수행실적이 높으며, 전략적 파트너 네트워크를 통해 전 세계적인 영향력을 발휘하고 있습니다.
모집부문 및 자격요건
모집분야
담당업무
모집인원
지원자격
Clinical Research
Associate
(New drug)
* Lead site identification and site selection
activities.
* Prepare for and attend investigator
meetings; may present materials.
* Develop and implement subject
recruitment strategies at the study and site level.
Review Monitoring Visit Reports (MVR) and
follow-up letters for compliance with ICH-GCP and the CMP; provide final
approved documents to Sponsor as required and track report metrics in
CTMS.
* Ensure appropriate issue escalation and
tracking of these to resolution, proactive identification of areas of
risk, and develop risk management strategies.
* Assist PM with response to audit
findings and assist the clinical team with completion of any CAPA review
and documentation.
* Work with PM to manage clinical
resources to ensure monitoring activities are within budget and notify the
PM of any changes required or changes in scope.
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학력 : 대학교(4년) 졸업
성별 : 성별무관
나이 : 연령무관
* Graduate in a clinical or life-science
related field.
* Must have working experience in managing
clinical operations deliverables & leading the CRA team across
multi-region in global/regional studies
* Need to demonstrate the working
experiences in clinical study deliverables, study quality &
system compliance management and creation of study plans,
understanding of vendor management
* Must have the ability to meet deadlines
in a fast and dynamic environment.
* Good communication skills and fluency in
both verbal and written English
