Position Summary
Lead and manage in planning, executing, monitoring, controlling and closing of a major or large scale projects with cross-functional project team(s) to ensure timely and cost effectively execution of various clinical trial activities with high quality and in accordance with ICH GCP, local regulatory requirements and the SOPs of dMed and/ or Sponsor.
Work with cross-functions to develop/ optimize the project management process. Take ownership of project management process and key deliveries.
Through effective communications, develop and maintain strong working relationships with internal functional lines within dMed and external stakeholders at various levels to display dMed values in how the team delivers against goals and demonstrates an entrepreneurial style of leadership in leading cross functional team.
The degree of responsibilities accorded to Sr Director, Director, or Associate Director will reflect their level of experience and contribution that they can make to the projects and clinical operations.
Key Responsibilities
- Project management leadership and accountability
- Be accountable for project planning, budgeting, initiation, execution, and close-out throughout the whole process of the project.
- Play project leadership role in cross-functions’ resources arrangement and coordination, resolution of issues/obstacles, timeline and quality control, as well as budget and cost management to ensure program/project is managed effectively and key milestone delivered timely.
- Collaborate with Business Development team and other cross functional teams, and drive the preparation of bidding budget, proposal and defense meeting presentation against the client requests for full-service projects; lead the defense meeting presentation and discussion with Sponsor.
- Serve as a primary contact with Sponsors and third-party venders and build up good and health connection and work relationship with external stakeholders.
- Work closely with Study Managers at the study level to make effort and drive decision points on the key milestones’ deliverables of various clinical trial activities with high standard quality and in accordance with ICH GCP, local regulatory requirements and the SOPs of dMed and/ or Sponsor.
- Predict and identify study quality issues trend and lead the project team to plan and implement appropriate mitigation, corrective and preventative actions within a pre-define timeframe; Escalate findings and action plans to line manager and internal executive management team and communicate with the stakeholders at appropriate timeframe.
- Oversee the third-party vendors on the trial to ensure their project deliveries on time and on budget with high quality at project level.
- Facilitate internal and external audits, as well as regulatory inspection.
- Work closely with finance to monitor project budget and resource allocation, as well as payments to all stakeholders.
- Company Business Support
- Lead the development and implementation of internal project management working process.
- Play a meeting manager and process owner roles for company level project management and governance meetings and processes respectively, which are related clinical project management and governance processes.
- Support and contribute company Business Development strategy plan.
- Identify training needs for project team members, facilitate trainings and training recording, provide ongoing coaching and feedback to the staffs to maintain a highly effective project team at project level.
- Provide performance feedback to project team members including recommended goals related to the projects, performance review, career guidance and developmental opportunities
Professional Experience & Education Requirement
- Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); Advanced Degree in biomedical sciences (MSc, PhD,) preferred.
- Minimum 6 years of experience in clinical trials of both site management (or equivalent) and study management, including project management preferred. For Senior Director, minimum 15 years or experience including 5 years in project management and/or people management.
- PMP accreditation will be a strong plus.
- Proficient communication skills in both Chinese and English.
- Present excellent performance and capability to project and team goal.
- Excellent working knowledge of GCP guidelines and good sense to regulatory requirements.
- Proficiency in Basic Microsoft Word, Excel, ppt and familiarity with use of database.
- Extensive knowledge of drug development process
Key Competency Requirement
- Strong project management and complex problem-solving skills.
- Excellent planning, organization and prioritization skills.
- Strategic awareness.
- Capability in effective decision making.
- Strong knowledge and experience in clinical project budgeting, cost tracking and analysis.
- Well-developed of communication (Chinese & English), presentation, and interpersonal skills.
- Teamwork and can-do working attitude.
- Customer orientation and focus on company.
- Excellent people leadership and team management skills, particularly may work in remote environment.
- Able to create engaged and innovation environment.
- Drive changes and continuous enhancement in process, quality, efficiency and capabilities.
职能类别: 医药技术研发管理人员 生物工程/生物制药
联系方式
上班地址:上海市浦东新区祥科路298号佑越国际,3楼301-305
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