Responsibilities:
a) The role as clinical trial project manager includes but is not limited to the following responsibilities
- Project initiation and planning: Confirm the requirements of the contract with the client, applicable SOPs and management systems, etc., establish a project team, and formulate various management plans of the project (project management plan, monitoring plan, risk management plan, communication plan, etc.) to ensure the correct setting and use of the project system.
- Project implementation and management: Promote and manage the project according to the established management plans, including project scope, time, cost, quality, resources, risks, etc., formulate and implement operational strategies and make timely adjustments and optimizations. Manage and supervise the whole process of site selection, initiation, monitoring, and close-out to ensure that the project is carried out in the site in accordance with the regulations, protocol, and project requirements.
- Team and vendor management: Lead and coordinate the cooperation of cross-department teams and third-party vendors; reasonably assign the responsibilities and tasks of project management team members, guide and support them to carry out work according to requirements.
- Contract and delivery control: Ensure compliance with contract stipulations and deliver to customers, and work with business, finance and other relevant departments to promote financial settlement and collection; conduct internal cost control and financial management of external suppliers based on contract quotation; when there are important changes in service scope, quantity or customer needs, work with business colleagues to timely promote contract changes.
- Clinical operations management: Take the sole as the Country Project Manager (Country PM) or Clinical Project Manager (Clinical PM), be responsible for the clinical operation management of a certain country in a multi-regional clinical trial (MRCT) or at site level clinical operation management of a single country trial, including but not limited to the entire process of site selection, SSU, monitoring, and close-down, the establishment and management of the CRA team, the progress, quality at site level, etc,. Ensure that the project level's operation plans are strictly implemented and the project goals are achieved.
- Customer relationship maintenance: Establish and maintain good cooperative relations with the sponsor, investigators and other partners during the implementation of the project, and demonstrate the professional level and corporate image of Tigermed.
b) The role of clinical trial project director includes but is not limited to the following responsibilities.
- Supervising the implementation of the project in compliance with relevant regulations, guidelines and company SOPs (Standard Operating Procedures); monitoring project progress, cost and quality to ensure compliance with contract and customer requirements.
- Review and approve the project management plans and core documents according to the SOP procedures.
- Review the implementation of project progress, quality, finance and other aspects according to SOP and departmental specifications, identify major risks and problems of the project, provide timely guidance and support to the project team, control and mitigate risks, and solve problems.
- Customer relationship maintenance: Establish and maintain good cooperative relations with the sponsor, investigators and other partners during the implementation of the project, and demonstrate the professional level and corporate image of Tigermed.
c) Business support and external Cooperation
- Support the Business Development to expand new business, support business bidding and competitive bidding, and contribute to order signing and business growth.
- Support good communication with customers at the company level and maintain a good cooperative relationship.
- Maintain good partnerships with experts in the field of clinical research.
d) Process optimization and system construction
- Participate in the construction of the quality management system, and participate in the writing or review of SOPs and related documents.
- Support various training efforts, share experiences, and empower teams.
- Participate in the development and promotion of relevant systems of the company.
e) Team management and talent development
- Support team leaders in personnel management, including attracting, motivating and developing the team to the level expected by the company. Provide mentoring and coaching to COM, lead by example of demonstrating the value in action of Tigermed. Implement and promote the company's strategic objectives.
- Manage team in charge, including performance appraisal management, team resource management, organizational capacity building, etc., promotion team cohesiveness and output.
Qualification:
a) Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements.
b) At least 8 years clinical trial experience, at least 6 years of independent project management experience. The excellent candidates will not be restricted to the current requirements.
c) Fluent in Chinese and English
