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.현재 비지니스 확장으로 인해 Project Manager(임상)포지션을 채용하고 있으니, 아래 내용 참고 부탁드립니다. 빠르게 성장하고 있는 글로벌 기업 Novotech과 함께 성장해나갈 여러분을 기다리겠습니다.
(2)채용 포지션:Project Manager(Global Study)
Responsible for the overall management of projects to ensure the adherence of the project to quality standards and the approved timeline and budget in the service agreements. Leads the project team and the internal/external communications and identifies suitable resources to facilitate efficiency improvement for project execution.
- Manage staff in accordance with organization’s policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.
- Provide input to line managers of their project team members’ performance relative to project tasks.
- Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
- Responsible for the overall project planning and execution of the project timeline, budget, scope, and quality regarding the assigned projects. Ensure accurate and timely communication with customers regarding delivery of work product and project progress.
- Work with the assigned personnel to prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical
- Responsible for import permits for investigational drug products and bio samples.
- Responsible for the trial documents preparation / tracking / filing and all operations complying with ICH, local regulation, SOPs and project plans.
- Work with the line manager of the project team member to facilitate issue resolution and resource management.
- Participate in the internal and external communication for issue identification / resolution and customer satisfaction. And ensure to follow the company SOP or project-specific QC processes for the tasks coordination to solve the emerging issue/problem as necessary.
- Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
- Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
- Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
- Evaluate potential sites and provide recommendations for the selection of qualified sites.
- Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements. Serve as CRA to conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations, and other applicable project-specific plans, if required.
- Assist in project quality management by accompanying CRAs during monitoring visits based on the requirements defined in the project-specific
- Responsible for participating and contributing to the BD project bidding and marketing activities, and to facilitate the success of business explore and contract award.
- Take on additional responsibilities that may be assigned by the line
Education and Experience:
- Minimum of a Bachelor's degree or equivalent in Science or medical related filed
- PM role :4-year relevant work experience in clinical operations or project management is preferred
Skills and Competencies:
- Familiar with activity processes throughout a clinical trial with good knowledge in ICH-GCP and local regulations.
- Excellent customer management and problem resolving skills
- To be proactive, flexible, organized, and aim to mitigate risk, understanding plans and outcomes fluctuate, and be highly communicative during the entire process
- Good in maintaining good working relationships with sponsors and project team members.
- Strong communication and interpersonal skills, fluent communication of speaking and writing in English is preferred.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Strong software and computer skills, including MS Office applications.
- 인터뷰는 서류검토 합격자에 한해, 지원순서에 따라 순차적으로 진행됩니다.
- 제출 서류: 자유형식의 영문 이력서 (Word/PDF 형식)
- 지원 방법: 홈페이지 지원 https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/1288/?utm_medium=jobshare
- 지원서 내용 중 허위사실이 있는 경우 채용이 취소될 수 있으니 신중하게 작성해 주시기 바랍니다.
서류전형->전화 인터뷰->실무진 면접->레퍼런스 체크->최종 합격
*유연근무제 실시 (Core time 없는 유연한 근무 지원)
*재택근무 지원금 제공 (home-office set up, Flexible allowance) / 자유로운 재택근무 환경
*넉넉한 휴가 일수 (연차20일~25일+ 병가10일) - 1시간 단위로 사용 가능
*경조 휴가 및 경조 수당
*명절보너스 (설날/추석) / 생일 상품권 지급
*단체보험 (실비 or 치과보험 포함) / 건강검진
*휴대폰 비용 지원
*Employee Assistance Program(임직원 심리 상담 서비스)
*Recognition Award(동료 칭찬 프로그램 포상)
-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.
-포지션 문의: firstname.lastname@example.org으로 연락주세요.