Position Summary:

Lead and manage major or large scale projects by own or lead project management team to ensure timely and cost effectively execution of various types of clinical trials with high quality and in accordance with ICH GCP, local regulatory requirements and the SOPs of dMed and/ or Sponsor.

Responsible for the project management oversight and resourcing for all contracted and assigned clinical trials to make sure the efficient plan and conduction of clinical trials with respect to functional expertise and operational excellent, including delivery of operational aspects from protocol development through effective study reporting and close-out; submission activities; and audits/inspections, as appropriate.

Work with cross-function to develop/ optimized the project management process. Take ownership of project management process and key deliveries.

It will be achieved through building, maintaining and developing a team of study management with appropriately qualified and trained staff. Through effective communications, and developing and maintaining strong working relationships with relevant functional lines in dMed and sponsor representatives, as well as related vendors. Able to display dMed values in how the team delivers against goals and demonstrates an entrepreneurial style in leading 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 and execution during the whole process of the project and provide end-to-end support
• Play project leadership role in cross-functions’ resources arrangement, coordination and issues/obstacles resolving, timeline management, quality oversight, as well as budget and cost management to ensure program/project is managed effectively and key milestone delivered timely
• Serve as primary contact with Sponsor in program or large scale of studies and build up good connections with clients
• Assign project managers at the study level, to make effort to achieve the key milestones for clinical trial
• Ensure project managers to appropriately communicate and collaborate with different functional team to meet client’s expectation, including but not limited to protocol writing, trial projection, study timeline, database lock, CSR etc
• Oversee project managers or study managers to ensure the conduction of clinical trials in accordance with ICH-GCP, local Regulatory requirements and applicable standards of dMed and/or sponsor, can meet study objectives and deliver commitments with sponsor on timeliness, quality and cost
• Oversee studies quality issues trend and ensure project team to implement appropriate corrective and preventative action. Escalate findings and action plans to appropriate parties
• Manage vendors to support the project delivery on time on quality
• Facilitate internal audits and regulatory inspection
• Work closely with finance to monitor project budget, resource allocation and milestone delivery, as well as facilitate milestone payment
• Keep positive work relationship with clients and key stakeholders to build trust and effective working relationship

• Lead process implementation and ensure overall compliance in project manager team
• Collaborate with business development team to prepare proposal, plan to support client request, bidding and bidding defense meetings to capture the business opportunities
• Responsible for the recruitment and development of project managers to ensure appropriate levels of skills to achieve clinical trial objectives. Build up team with high competency
• Identify training needs for staffs, facilitate trainings and check training records, provide ongoing coaching and feedback to the staffs to maintain a highly effective study management team
• Optimize team competency by overseeing team responsibilities, process improvement, promote a culture of quality and efficiency assessment
• Manage performance of project managers including goal setting, performance reviews, career guidance and developmental opportunities
• Identify knowledge and skills gap based on business and career goals to support staffs to achieve job and personal development goals
• Provide input for the development of proposals for new work n Demonstrate a strong leadership in leading the project team to achieve project objectives and department objectives
• Maintain good relationship and knowledge sharing communication with internal functional lines and Sponsor
• Actively create an environment of openness, innovation and inclusiveness that promote effective change

• Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); Advanced Degree in biomedical sciences (MSc, PhD, MBA) preferred
• Minimum 12 years of experience in clinical trials of both site management (or equivalent) and study management, including no less than 3 years project management. 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
• Present excellent performance and capability to project and team goal
• Good 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
• 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

上班地址：上海市浦东新区祥科路298号佑越国际，3楼301-305