코반스 (Parent company: LabCorp)는 지속적인 성장과 체계적인 시스템 및 업무환경의 Global Top tier CRO로서, 매년 비지니스 확장과 직원수 증가로 현재 전세계 6만명 이상의 직원들이 근무하고 있습니다.
코반스 코리아는 Global CRO 중에서도 유일하게 전체 Spectrum, 즉 전 임상부터 Commercial 까지 Full service를 제공할 수 있는 유일한 CRO입니다. 한국은 2005년에 Legal entity 를 설립한 이후 1상부터 4상까지 다양한 indication 의 임상시험을 진행하고 있고, 정확하고 전문적인 성과로 더 크게 성장하고 있으며 직원들에게는 더 많은 커리어 기회를 제공하고 있습니다.
Typically under the direction of a Sr. Project Manager/Project Director, the Project Manager oversees and manages domestic, regional and/or international clinical trials. Responsibilities typically include developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks.
The Project Manager also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data. The Project Manager may have line management responsibilities.
- Lead core project team and facilitate team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
- Serve as escalation point for CRA issues
- Resolve conflicts as needed
- Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Covance and client requirements
- Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
- Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director
- Provide performance feedback of team members to respective supervisors
- Present at external and/or internal meetings
- Define and manage project resource needs and establish succession plans for key resources
- Create required project plans. Implement and monitor progress against project plans and revise as necessary
- Responsible for appropriate issue escalation to CAIR program and/or appropriate stakeholder(s)
- Serve as key client contact for assigned project(s)
- Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks
- In lieu of the above requirements, candidates with > six (6) years supervisory experience in a health care setting and five (5) years clinical research experience with at least one (1) year project management experience in the pharmaceutical or CRO industries will be considered
- Experience in Biosimilar or Cell&Gene Therapy is highly preferred
- Experience in multiple location including APAC
- Detailed knowledge of financial control procedures (i.e. costing systems, time reporting)
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Broad knowledge of drug development process and client needs.
- Masters or other advanced degree
- PMP certification
- Working knowledge of Covance and the overall structure of the organization
- Basic knowledge of Covance sales and business development strategies and procedures
- Working knowledge of Covance SOPs
University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
Master or other advanced degree
- Minimum of five (5) years of relevant clinical research experience in a pharmaceutical company/CRO.
- In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a heath care setting and (b) five (5) years clinical research experience including one (1) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered
- Preferred: Regional project management experience
On the Job Experience:
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Experience managing projects in a matrix and virtual environment
- Excellent communication, planning and organizational skills
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
- Financial awareness and ability to actively utilize financial tracking systems
- Working knowledge of project management processes
- Ability to work independently and mentor junior project team members
- Ability to negotiate and liaise with clients in a professional manner
- Ability to present to staff at all levels
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