南京招聘

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 

1. Be accountable for project planning, budgeting, initiation, execution, and close-out throughout the whole process of the project .
2. 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.
3. 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.
4. Serve as a primary contact with Sponsors and third-party venders and build up good and health connection and work relationship with external stakeholders.
5. 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.
6. 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.
7. Oversee the third-party vendors on the trial to ensure their project deliveries on time and on budget with high quality at project level.
8. Facilitate internal and external audits, as well as regulatory inspection.
9. Work closely with finance to monitor project budget and resource allocation, as well as payments to all stakeholders.

• Company Business Support

1. Lead the development and implementation of internal project management working process.
2. 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.
3. Support and contribute company Business Development strategy plan.
4. 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.
5. Provide performance feedback to project team members including recommended goals related to the projects, performance review, career guidance and developmental opportunities.

• 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. 
• 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.

• Strong project management and complex problem-solving skills.
• Excellent planning, organization and prioritization skills.
• 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.

备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。
 
我们是谁？
 
    基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:
· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理
· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。
 
为什么选择我们？
 
· 缔脉定位于以高品质服务和专业精神成为业界典范。
· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。
· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。
 
创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。