职位描述

职位描述： Your challengeYour challenges are to use your clinical research skills to develop and deliver clinical evidence to internal & external stakeholders to further innovation & optimize product life-cycle with flawless execution.Your responsibilitiesAs a Sr. Clinical Research Specialist you are responsible for:?Site Monitoring & Management:oManage study activities at assigned investigational sites.oVerify the quality of the investigator and the suitability of the sites by performing study feasibility or site evaluation visit to ensure the site is qualified and suitable to conduct the study.oRe involved in the preparation of the documentation for submission to EC.oEnsure the smooth negotiation process on the site contract sign-off. Be responsible for site payment is properly paid according to the agreement.oPerform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations and ICH GCP. Prepare and submit accurate and timely site visit reports for all performed visits.oKeep and maintenance the TMF and SRF to ensure it is up to date, complete and accurate according to company SOPs, regulations and ICH GCP.oVerify the accuracy, completeness and legibility of the data collected in the studies;oEnsure all case report forms can be collected and queries can be resolved in timely manner;oEnsure all adverse events occurred in the study be reported in compliance with study as well as regulation requirement;oVerify the trial supply is stored, transferred and tracked appropriately. And unused investigational product and other study supplies is returned or destroyed properly after the completion of study.oAssist in the preparation for the internal or external audit/ inspection. Resolve issues cited in audit reports.?Project ManagementoSet up and lead the project team to ensure the study is implemented according to company policy, SOPs and relative regulations.oPrepare the study request form and coordinate the protocol and other study documents development and approval process;oLead the project team to accomplish the proposed timeline;oCommunicate with internal and external business partner in terms of project progress and outstanding issues;oEvaluate the potential investigational sits for a specific study in terms of the qualification of the investigator and the suitability of the sites;oEvaluate the CRO, provide evaluation assessment to line manager;oActively guide and coach CRAs in the study team;oCoordinate with Data Management, Statistician and Medical Writer to ensure the deliverable on time.?Vendor ManagementoPerform vendor selection and continuous quality and compliance tracking and evaluation;oPerform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with Philips policy, SOP and other related requirements.Your teamYou will report directly into the Sr. Manager, Clinical & Scientific Affairs-China. Clinical & Scientific Affairs China team is part of Global Clinical Affairs team, work closely with Greater China Q&R team to support the China product registration via generating the clinical evidence. You will have close interaction with Global/BU clinical team, China Regulatory affairs and other cross-functional team as well as key opinion leaders and investigators.Our offerWe offer you the opportunity to work on delivering the evidence and growing the people who contribute to it. Join us and you can provide your deep insights that accelerate innovation and drive value and safety for patients and customers everywhere.We are looking for?Bachelor’s degree & above, clinical medicine or life science preferred.?Minimum of 3 years’ experience in a pharmaceutical or medical device company for clinical research execution, including at least 1 year project management experience.?Site assessment/monitoring experience is required?Be able to collaborate effectively with the Clinical Operations team, cross-functional team members, and external partners?Demonstrated communication / interpersonal skill (oral and written).?Fluent in English reading & writing?Self-motivated individual who is able to manage multiple tasks and priorities in an efficient manner?Proactive attitude?Conscientious and precise delivery of work even when under pressure 职能类别： 临床研究员 临床协调员

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