Medical Operations Lead 上海

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述： The MOL will be responsible for management, general oversight and direction for Medical Services projects, including medical monitoring, clinical endpoint and data monitoring and review, and clinical and post - marketing PV projects. The MOL will also be responsible to provide input, advice and direction for project resource planning and allocation, and overall Medical Services project team management, The MOL will also be a point of communication contact and liaison with internal and external stakeholders, strategic planning teams and project review teams including Quality, financial performance and customer feedback. The MOL will be responsible for consistent and complete communication between all members of the WorldwideMedical Services project team, between the global Medical Services team and the PL and other members of the project team (such as DOL and COL), and between the global Medical Services team and the client. If acting in the GMOL role, the MOL will be the single operational point of contact in Medical Services for this communication.The MOL will represent Medical Services as Bid Defense Meetings and cover topics related to PV Operations.In activities involving project management, the MOL will be acting as the Medical functional lead working with the overall PAREXEL PL (or as the Project Leader(PL) if a the project is a function-led [“standalone”] Medical project, to ensure that projects run on time, on budget, and in accordance with client contract, SOPs, quality standards and regulatory Projects may involve the following tasks:? Clinical trial safety management – receipt, processing, data-basing, follow-up and regulatory reporting of SAEs.guidelines.? Clinical trial medical monitoring – review of endpoints, lab alerts and waivers.? Clinical trial cumulative and/or per-patient data review? Management of Data Monitoring Committee (DMC) and Clinical Endpoint Committee (CEC): communication with client, team members, DMC and CEC consultants.? Post-marketing PV - receipt, processing, data-basing, follow-up and regulatory reporting of spontaneous adverse drug reactions (ADRs), conduct and review of literature searches, preparation and submission of PSUR/DSURs.? Any other activities as required by lifecycle drug safety services.In addition, the MOL will be responsible to provide input, advice and direction for resource planning and allocation working closely with the global Medical Services resource planning office, project team management, stakeholder liaison, strategic planning and reviews:? Management, support, direction, coordination and planning for any medical and other pharmacovigilance (PV) related activities, including oversight of and contribution to PV consulting projects.? Strategic input, including providing subject matter expertise in the planning and setup of PV projects, including costing, budgeting, resourcing, workflow and process design and analysis.? Provide training and mentoring to other, less experienced MOLs and Drug Safety Staff.? Timely contribution to and strategic input and review of proposals (RFP), and contracts as required.? Liaison with internal (e.g. business operations, account management, PAREXEL Consulting) and external stakeholders (e.g. clients, third party vendors, health authorities).? Represent Medical if and when required for internal and external matters.? Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate.? Contribute to Medical and PV Operations resource planning and strategy.? Contribute to the costing of Medical and PV Operations projects, including the review of and improvement of performance metrics and costing tools.? Attend and lead client meetings, and bid-defense meetings.? Provide timely input and feedback to process improvement.Job Qualifications : Skills:? Excellent knowledge of drug safety and the drug development process? Excellent knowledge of and ability to interpret and apply global safety and other relevant regulations? Experience in evaluation of safety data and the preparation of safety reports? Experience with computer applications including database management and pharmacovigilance related computing systems? Leadership skills – ability to build effective project teams, ability to motivate others, delegation skills, drive and timely/quality decision-making? Personal qualities – ability to gain trust and confidence with a variety of clients as well as within? PAREXEL, good learning ability, managerial courage, action oriented and resilience in a fast- paced and rapidly changing environment? Business/Operational skills – customer focus, commitment to quality management and problem solving? Influencing skills – negotiation and teamwork? Effective communication skills – provision of timely and accurate information to stakeholders and strong written and oral communication skills? Knowledge of business operating procedures (e.g. contract approval, revenues recognition, project close out)? Working knowledge of the PAREXEL financial and information tools (e.g. PERFORM, Portal, TIME, Impact Harmony, ARGUS, ISIS)? Basis knowledge of accounting (AP, AR)? Proficient use of MS Office SuiteExcellent command of verbal and written English and Mandarin ChineseKnowledge and Experience:? Considerable drug safety knowledge and experience? Substantial experience working in drug development and/or healthcare environment? Project management and/or significant team leadership experienceEducation:? Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification? Associates/diploma degree in any of the above with appropriate work experience 职能类别： 医药技术研发管理人员

联系方式

上海市浦东新区银城中路488号太平金融大厦20层

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1.    在线投递； 2.    请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！

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