職位描述
工作職責:
Duties and Responsibilities:
? Responsible and accountable for one or more clinical trial(s).
? Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).
? Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
? Responsible for effective communication within the Clinical Project Team and with functional management.
? Provides regularly updates regarding the status and progress of the trials (Therapeutic Lead, Business Alliance, etc.)
? Manages the project(s) within the approved budgets and timelines.
? Responsible for writing of clinical project deliverables such as protocol, final study report, study manuals, study tools, operational plans, etc. within the CPP framework.
? Prepares investigational site lists and participates in reviewing and approving investigational sites.
? Directs forecasting of devices necessary for project in collaboration with supply-chain; reviews and approves various support system specifications (e.g. IVRS, etc.).
? Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team.
? Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
? Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.
? Prepares and presents the status of the clinical project(s) to the Clinical Management Board.
? Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.
? Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable MicroPort SOPs and policies.
? Represent the company at Investigator/ Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings.
? Participate in external and internal audits/inspections, as required
任職資格:
Competency Expectations:
Ability to understand strategic goals and match the business needs of the company. Ability to develop good interpersonal relationships with medical professionals. Good verbal and written communication and presentation skills. Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies. Ability to independently manage and provide significant tactical and leadership guidance to clinical team. Independently motivated. Demonstrated ability to manage multiple projects, complex projects and international projects.
Working Conditions:
General office environment, approximately 10-30% travel to research laboratory or hospital settings, meetings and other MicroPort facilities. Potential exposure to blood borne pathogens and other potentially infectious materials
