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.
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.
- 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
Job Description: https://novotech.bamboohr.com/jobs/view.php?id=1050
• 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
- 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
- 지원서 내용 중 허위사실이 있는 경우 채용이 취소될 수 있으니 신중하게 작성해 주시기 바랍니다.