Clinical Operations Manager招聘_科文斯医药研发（上海）有限公司最新招聘信息-猎才医药网

职位描述

职位描述： Clinical Operations ManagerClinical Operations Manager is responsible for the management of a team of CRAs and has overall responsibility and accountability for the execution of the clinical operations strategy of the projects. The position requires proactive interactions with all levels within Covance and clients and will also be responsible for assisting other Covance staff in business development activities related to clinical research operations. The multiple management skills will be strongly practiced through the daily tasks. Covance is committed to provide a long term career development with purpose in a culture that values achievement. By joining our team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds - giving you an excellent overview of best practices across the industry. Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global trials. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.Job Duties:A. GCP and Quality Oversight:? Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented? Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits? Ensures training record compliance with training matrix and ensures training records are up to date? Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff? Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins? Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate? Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables? Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local levelB. Productivity and Financial Management:? Communicate status of assigned workload for metric reporting? Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation? Escalates available workload hours, in context of project allocation, supply and demand, to management team? Adheres to global tools for monitoring and utilization forecasting? Engage in Resource management activities for direct reports? Assist with staff recruitment through screening and interviewing? Financial authority in accordance with current signature approval matrix? Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports? Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma? Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity? Schedule Accompanied Field Visits to ensure costs are in alignment with regional budgetUtilization of direct reports in conjunction with the Country Lead and Management Team.Requirements: A. Travel: Yes? 30-50% travel by plane and car as required with overnight and domestic/potential international travel? Ability to drive and have a valid driver’s license as appropriate per country travel normsB. Language Skills:? Speaking: English and Local Language required? Writing/Reading: English and Local Language requiredC. Education/Qualifications? University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)? In lieu of this required educational background the following relevant work history may be considered:? Minimum of three (3) years supervisory experience in a health care or clinical research setting and? Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CROPreferred:? Masters or other advanced degreeD. Experience? Relevant clinical research experience in a pharmaceutical company or CRO? Individual is proficient with on-site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)? Minimum of five (5) years relevant clinical research experience in a pharmaceutical company/CRO? Thorough knowledge of drug development process? Thorough knowledge of relevant SOPs, ICH, and GCP guidelines? Relevant supervisory experience? Minimum of 1 year as a Line Manager or Project Manager required? Demonstrated ability to lead by example and to encourage team members to seek solutions? Proven interpersonal skills? Demonstrated ability to successfully participate as a member of a project team? Demonstrated ability to successfully manage multiple competing priorities? Excellent planning and organizational skills? Excellent oral, written and presentation skills 职能类别：医药技术研发管理人员生物工程/生物制药关键字： covance 科文斯生物制药生物医药 COM Clinical Operations Manager

公司信息

Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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