SUMMARY
The Clinical Project Manager (CPM) will is an expert on running various clinical activities such as clinical trials, limited releases and focus groups related with medical devices. The CPM will ensure that clinical activities are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials or limited release meets the regulatory requirements for approval. The CPM may also assist other departments to execute post marketing studies of approved products either to comply with regulatory approval conditions or to generate additional clinical information for marketing purposes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
•Leads planning and communication with cross-functional teams to ensure proper execution and conduct of clinical activities.
•Serves as resource and lead expert for clinical affairs team
•Tracks and reports on the progress of clinical activities being run including budget and timelines.
•Preparation, oversight and review of clinical affairs projects and programs related documents
•Participate in the preparation, review, updating and training of SOPs.
•Works to improve and innovate ways to make processes and procedures more efficient and effective
•Lead in helping CRAs perform uations of potential investigational sites and investigators for participation in clinical activities
•Perform audits of investigational sites and investigators to ensure data integrity and protocol compliance
•Lead and provide guidance to CRAs in assist with negotiating and obtaining approval for investigator agreements
•Lead in helping CRAs with creation of monitoring plans for each clinical study
•Lead and provide guidance to CRA for preparing IRB submission applications and obtain IRB approvals
•Assist in preparing Clinical Study Reports and annual IND safety reports.
•Lead CRA to educate, train and support investigators and their staff prior to and during clinical trials of investigational devices (or limited releases of approved products)
•Assist with managing external vendors, CROs, etc
•Lead and guide CRAs in development of clinical protocols, case report forms, informed consent forms, investigator manuals, product instructions for use, and study training materials
•Be the lead with preparing clinical documents for IRB submission
•Lead with preparing clinical trials deions on clinicaltrials.gov
•Lead and guide CRA in activities associated with clinical site start-up, monitoring, and collection of data through to study close out
•Work with CRA and data management team to resolve data queries and to ensure data integrity and completeness
•Person must have excellent organizational skills and pay extreme attention to detail.
•Person must have excellent interpersonal and oral/written communication skills and be able to work independently.
•Other duties as assigned
•Travel may be required up to 25%

Working Relationships:
•Internal - Position interacts on a regular basis with all members of the Regulatory Affairs, Legal, Product Innovation, Marketing and with members of other departments as a representative to internal project teams as appropriate.

•External – Position interacts with investigational site personnel including investigators, their staff, clinical and administrative personnel contract monitors, and data management. External inter includes Institutional Review Boards (IRB), contractors, consultants and Contract Research Organization (CRO) for research.
Decision-Making Authority:
•This individual will make decisions together with the Manager of Clinical Research and will at times be required to make critical independent decisions when working with investigational sites and IRBs.
•The individual must possess highly effective interpersonal skills enabling them to lead a team through negotiation, coaching and mentoring, have a strong understanding of clinical studies including ICH-GCP guidelines and applicable regulatory requirements, and display flexibility and integrity.
QUALIFICATIONS
•Bachelor of Science, or equivalent experience, required
•Masters of Science preferred
•7-10 years’ experience in clinical research in medical device industry
•Minimum of 2 years experience as senior clinical research associate
•Dental industry experience required
•Experience running clinical studies from a project management perspective preferred required
•Well organized and detail oriented person with strong written and verbal communication skills, be proficient in MS Office Suite, and have the ability to give presentations, multi-task and work effectively in a team or independently on assigned tasks.

爱齐（上海）商贸有限公司是美国Align Technology Inc. 我们的产品为隐形牙套，是Align Technology专有的产品，在全球100多个国家销售，并于1998年通过美国食品药品管理局（FDA）审批。Align Technology Inc. 于2000年在美国纳斯达克上市，全球至今已经有几百万患者使用过Invisalign隐适美产品。
爱齐公司强调创新、以结果为导向、以客户与团队合作为中心、自我领导的能力与精神，为员工提供多元化的发展空间，并为员工创造学习、友好、合作、健康的工作环境。
我们在中国成立六年多，已经成功建立了市场品牌并开始商业运作，我们竭诚邀请充满工作激情，具有挑战精神的精英加入到我公司，共同创造你与公司的成功！