- 无工作经验
- 本科
- 招1人
- 11-09 发布
- 五险一金
- 免费班车
- 弹性工作
- 定期体检
- 年终奖金
职位描述
职位描述: PURPOSEUnder general supervision, manage the process of designing and launching single region, less-complex global/regional clinical research studies under general direction; lead activities of the Sponsor/Clinical Research Organization (CRO), and guide the Project Manager (PM) and Set-up Coordinators (SC) in designing and organizing project components during Start-Up.RESPONSIBILITIES??Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable in accordance with the requirements of the Clinical Protocol.??Perform database configuration and programming review and approve verification unit testing??Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.??Responsible for providing updates to the Project Manager regarding action/issues logs, status sheets and timelines during the start-up phase.??Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved.??Lead in the development of sponsor specific standards and program-specific set-up procedures.??Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally.??Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate.??As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings.??Participate in external and internal audits as required.??Coordinate and mentor more junior staff; may assist in training new staff.??Report on team performance against contract, customer expectations, and project baselines to management.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES??Possess strong interpersonal skills??Demonstrated ability to meet deadlines.??Demonstrated computer proficiency with Microsoft Office??Working knowledge of Clinical Trials Management Systems would be an advantage [examples QLIMs, NewLIMs,TOPCAT, Encompass].??Possess an understanding of medical and clinical research terminology.??Demonstrated ability to work in a fast-paced, high stress environment.??Knowledge of Project Management processes and terminology.??Excellent organizational and time management skills??Excellent accuracy and attention to detail skills??Strong written and verbal communication skills written & spoken, influencing & negotiating??Excellent inter-personal skillsMINIMUM REQUIRED EDUCATION AND EXPERIENCE??Bachelor's degree or equivalent education and experience; science related background is advantageous but is not essential??Minimum 3 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experiencePHYSICAL REQUIREMENTS??Extensive use of telephone and face-to-face communication requiring accurate perception of speech??Extensive use of keyboard requiring repetitive motion of fingers??Regular sitting for extended periods of time 职能类别: 医药技术研发管理人员
联系方式
亦庄大族企业湾
公司信息
Q2 Solutions is a global clinical trials laboratory services organization formed as part of a joint venture transaction between QuintilesIMS and Quest Diagnostics. It comprises Quintiles’ former Global Central Laboratories, BioAnalytical/ADME and genomics businesses and Quest Diagnostics’ former clinical trials business. Q2 Solutions was born out of a shared commitment to quality, customer service and – above all – helping bring new treatments to patients. Q2 Solutions helps biopharma, medical device, and diagnostic customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is committed to providing our customers an innovative, progressive and responsive partner with the quality focus, global experience and deep medical expertise integral to drug, medical device, and diagnostic development. - See more at: http://www.q2labsolutions.com/about-us#sthash.TKFpb15K.dpuf
北京相关职位
-
外贸助理 4.5-6千/月
-
医药代表 2万以下/年
-
北京学术代表实习生 2-3千/月
-
销售工程师/*** 1.5-2千/月
-
高级销售代表(麻醉呼吸产品-医疗器械)-Sales-北京 15-20万/年
-
医学部药物警戒实习生 3-4.5千/月
-
医院资源维护经理 0.8-1万/月
-
质量管理员 5-8千/月
-
产品经理 2-2.5万/月
-
河北省招商经理 6-8千/月
-
物流配送员 (职位编号:4808) 4.5-6千/月
-
生物实验员及质检质控 6-8千/月
-
公共事务经理 (职位编号:lianluo000851) 1.5-2万/月
-
分子生物学研发工程师 4-8千/月
-
质控上机实验员-00066 (职位编号:00066) 4-8千/月