Clinical Research Specialist 上海

月薪：

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： KEY ACCOUNTABILITIES:？Establishes Study Timelines, Budget, Resource, Risk and Quality Plans synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures1). Develop study synopsis, protocol, feasibility conduct and all study specific documents and procedures2). Oversees project, protocol and site feasibility and determines site selection and patient allocation3). Based on project chart, prepare integrate project plan to set study timeline, budget, resource, quality and risk.a. Develops country level study timelines according to the result of protocol/site feasibilityb. Establish country-level recruitment strategy/planc. Develops budget plan, and forecasts using appropriate tools, ensures the study team has the appropriate resources to effectively deliver high quality studies on time and within budgetd. Develops resource plan according to sites and patients allocatione. Develops study communication plan and monitoring planf. In pre-market study, sets study drug management plan？Manage the Delivery of Study Activities in Order to Meet Study Plans1). Generate clear work breakdown structure to make each study member understand his responsibility2). Ensure study progress is in accordance with baseline project timelinea. Is accountable for timely achievement of key study milestones(EC approval, site initiation, first patient first visit, last patient first visit, last patient last visit, data frozen, etc.)b. Prepare and conduct outsourcing vendor selection. Act as a key contact with outsourcing vendor for proposal, interview, evaluation and contract. Submit vendor evaluation form for final approvalc. Prepare proposed site lists and patient allocationd. Device management (pre-market trial):·Complete device rolling forecast within request leading time·Continuously review device status report and ensure its accuracye. Safety management:·Ensure SAE reporting to PI/EC according to regulatory timeline and procedure·Complete SAE reconciliation according to the timeframef. Propose the contents of the investigator meeting and assign respective responsibility in the meeting among study teamg. Review and approve study related contracts (with external vendors or with sites).h. Establish and update study country information in CTMSi. Chair regular project review meetings where study progress and quality issues could be discussed and resolvedj. Ensure to setup and maintain trial master file3). Supervise the conduct of the study is in accordance with quality plana. Ensure studies are performed in compliance with protocol, ICH-GCP guidelines, Medtronic SOPs, local operating guidelines and all applicable regulatory requirements and quality planb. Leads and/or organizes (or assists in organizing) and/or participates in local or regional meetings and training sessions (i.e., Investigator Meetings, Monitor’s Workshops, and CRO training.)c. Monitor key risk indicators which have been identified in quality plan. Ensure patient safety and data quality concerns are escalated and resolved appropriately (e.g. non-compliance in monitoring visits or AE occurrence)d. Review information uploaded to CTMS and project tracking tools. Query and correct any deviation or incomplete informatione. Ensure monitoring reports are timely, reviewed and takes appropriate action for follow up on site issuesf. Conduct co-monitoring visits in align with quality plan or for cause during the study. Complete co-monitoring reports and supervise monitor to correctg. In case of any quality deviation or other issues, lead study team to identify the route cause and to make follow up actions until resolutionh. Draft any possible slides or posters in study training or results delivery, including the slides or posters presented at domestic or international conferences.4). Oversee the management of the studies budgeta. Ensure study expense is within reasonable variance of approved budgetb. Review medical study expense reports and SAP study expense reports. Ensure each payment is accurate and is timelyc. Supervise study expense to ensure its compliance with approved budgetd. In case of any variance during the study, adjust budget phasing at least quarterly, however reasonable explanation should be providede. Timely complete accrual form according to FA requirement5）Collaborate with different functions (QA, RA, legal, etc) and global organization and work on all aspects of study management.REQUIREMENTS:-At least 5 years proven experience in clinical operation-Project management experience preferred-Bachelor degree in biomedical/science discipline or above-Good understanding and knowledge of GCP and clinical trial operation processes/ procedures-Strong self-management and communication skills-Good English in written and spoken-Demonstrated ability to interact with different professional levels of the research community-Ability of influencing and negotiating at all levels to achieve team delivery-Excellent written and verbal communications skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organization-Demonstrated ability to prioritize and manage multiple tasks-Strong computer skills - experience using various computer applications including spreadsheets, email, word-processing software-Domestic and International travel required 职能类别： 临床研究员 临床协调员 关键字： 医疗器械 临床研究员

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About Medtronic Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others. We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.

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