项目经理/主管 PM/SPM

该职位来源于猎聘 Reporting To PM Director Position description: Responsible for the overall management of projects to ensure the adherence of the project to quality standards and the approved timeline and budget in the service agreements. Leads the project team and the internal/external communications and identifies suitable resources to facilitate efficiency improvement for project execution. Responsibilities:  Manage staff in accordance with organization’s policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role.  Provide input to line managers of their project team members’ performance relative to project tasks.  Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.  Responsible for the overall project planning and execution of the project timeline, budget, scope, and quality regarding the assigned projects. Ensure accurate and timely communication with customers regarding delivery of work product and project progress.  Work with the assigned personnel to prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.  Responsible for import permits for investigational drug products and bio samples.  Responsible for the trial documents preparation / tracking / filing and all operations complying with ICH, local regulation, SOPs and project plans.  Work with the line manager of the project team member to facilitate issue resolution and resource management.  Participate in the internal and external communication for issue identification / resolution and customer satisfaction. And ensure to follow the company SOP or project-specific QC processes for the tasks coordination to solve the emerging issue/problem as necessary.  Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.  Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.

 Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.  Evaluate potential sites and provide recommendations for the selection of qualified sites.  Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements. Serve as CRA to conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations, and other applicable project-specific plans, if required.  Assist in project quality management by accompanying CRAs during monitoring visits based on the requirements defined in the project-specific plan.  Responsible for participating and contributing to the BD project bidding and marketing activities, and to facilitate the success of business explore and contract award.  Take on additional responsibilities that may be assigned by the line manager. Qualifications: Education and Experience:  Minimum of a Bachelor's degree or equivalent in Science or medical related filed  PM role :4-year relevant work experience in clinical operations or project management is preferred Skills and Competencies:  Familiar with activity processes throughout a clinical trial with good knowledge in ICH-GCP and local regulations.

 Excellent customer management and problem resolving skills

 To be proactive, flexible, organized, and aim to mitigate risk, understanding plans and outcomes fluctuate, and be highly communicative during the entire process  Good in maintaining good working relationships with sponsors and project team members.  Strong communication and interpersonal skills, fluent communication of speaking and writing in English.  Demonstrated ability to deliver results to the appropriate quality and timeline metrics.  Strong software and computer skills, including MS Office applications.