노보텍아시아코리아
공고
2022년 11월 16일
위치
서울,경기,
카테고리
CRA  LM  PM  기타  
채용 형태

Description

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.

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

 

채용정보: Clinical Lead / Sr. Clinical Lead

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.

Responsibilities

  • Lead site identification and site selection activities.
  • Lead set up of clinical components in CTMS
  • Prepare for and attend investigator meetings; may present materials.
  • Develop and distribute Clinical Monitorring Plan (CMP) and update as required
  • Develop and distribute Site Initiation Visit (SIV) materials.
  • Develop and distribute Source Data Verification/Monitoring tools and trackers.
  • Develop and distribute annotated report templates and templates for visit confirmation/follow-up letters in accordance with any Sponsor requirements.
  • Review Site Activation Forms and related essential documents; assist PM and/or Regulatory Start-up Manager (RSM) with Project and Country Activation Forms as requested across regions.
  • Work with PM and/or RSM to coordinate initial shipment of both IP and non IP supplies across regions. Work with PM for re-supply of IP and non-IP.
  • Lead the CRA team to ensure all study materials are in place before SIV.
  • Lead internal meetings/teleconferences with the CRA team.
  • Prepare site newsletters/emails to keep site staff informed of key communication.
  • Ensure the clinical team are adequately trained on project-specific requirements.
  • Develop and implement subject recruitment strategies at the study and site level.
  • Supervise CRAs to discuss subject recruitment strategies with sites, update recruitment projections, and improve site productivity.
  • Review CTMS compliance reports for clinical project team and follow up on gaps.
  • 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.
  • Track the resolution of follow-up issues from site visits.
  • Maintain protocol deviation tracking in CTMS
  • Ensure appropriate issue escalation and tracking of these to resolution, proactive identification of areas of risk, and develop risk management strategies.
  • Oversee safety reporting processes to ensure in line with regulatory requirements.
  • Provide guidance to CRAs and IHCRAs through mentoring.
  • Oversee data collection and query resolution throughout the projects.
  • Oversee and coordinate the timely review and documented reconciliations of the TMF at the indicated timepoints per the project filing plan.
  • 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.
  • Assist PM to oversee the timely completion of site and investigator payment in accordance with the schedule detailed in the Clinical Trial Agreement.
  • May perform co-monitoring visits for ensuring site quality and CRA’s monitoring performance as request.
  • Oversees study transition plans of CRAs, ensures filing of the transition document/checklist.
  • Coordinate with PM and CRAs for Database Lock (DBL) and all close-out activities.
  • Oversee site close-out activities of the CRA team

  

지원요건 및 우대사항

• Must have clinical study management experience at an advanced level

• Regional experience as a Project Manager or lead role would be advantageous

• Relevant experience in regional areas outside of Korea is highly preferred

• Effective leadership and organisation skills as well as the ability to work proactively with challenging situations

• Strong communication skill both in written and spoken Korean & English

 

지원 방법

- 인터뷰는 서류검토 합격자에 한해, 지원순서에 따라 순차적으로 진행됩니다.

- 제출 서류: 자유형식의 영문 이력서 (Word/PDF 형식)

- 지원 방법: 아래 사이트에 접속 후 포지션별 온라인 입사지원서 제출

* Job Apply: https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/1297/?utm_medium=jobshare

- 지원서 내용 중 허위사실이 있는 경우 채용이 취소될 수 있으니 신중하게 작성해 주시기 바랍니다.

 채용 절차

 

 기타 참고사항

- 근무형태 및 근무일: 정규직, 주 5일 근무

*Full Flexible Working Hours - 주 40시간 범위에서 자유로운 근무시간 선택

*재택근무 가능 / 재택근무 home-office 셋업

*연차(20일)와 병가(10일) 모두 최소 1시간 단위로 사용 가능

- 근무지: 서울 강남구 테헤란로 87길 도심공항터미널 빌딩 4층 (2호선 삼성역/9호선 봉은사역과 코엑스몰 통해 지하연결)

- 진행단계에 대한 안내 및 전형결과는 등록하신 이메일로 개별 안내 드립니다.

로그인 이후 지원하실 수 있습니다.

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