[Novotech] Clinical Lead

회사정보

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.

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*현재 비지니스 확장으로 인해 Clinical Lead 포지션을 신규 채용하고 있으니, 아래 내용 참고 부탁드립니다. 빠르게 성장하고 있는 글로벌 기업 Novotech과 함께 성장해나갈 여러분을 기다리겠습니다. ​

채용정보: Clinical Lead (Global Study)

Brief Position Description:
The Clinical Lead (CL) and Senior Clinical Lead provides direction and guidance to multi-country clinical teams in assigned project(s), coordinates site management and monitoring activities, and provides operational leadership for clinical teams to achieve project deliverables.

Minimum Qualifications & Experience:

• 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

Responsibilities: 

• 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.

서류전형->전화 인터뷰->1차 면접->2차 면접->레퍼런스 체크 ->최종 합격