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Project Director-Clinical Research

希奥莱姆医药科技咨询(上海)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2013-06-20
  • 工作地点:上海
  • 招聘人数:1
  • 语言要求:英语良好
  • 职位类别:其他  

职位描述

responsibilities in accordance with project contracts, contract amendments and Company policies, procedures and SOPs.
? Develop and maintain close working relationship with client’s study management teams to ensure client satisfaction, operational and
customer service excellence.
? Ensure successful design, implementation, tracking and maintenance of project plans for assigned projects.
? Direct strategic aspects of assigned studies including oversight of day?to?day project operations and third party vendor activities.
? Working with the Company functional areas, determine appropriate revenue forecasting and revenue recognition based on project
plan, budget and contract deliverables.
? Proactively track budget and scope changes, obtaining necessary client approvals for change in scope of work. Initiate and follow up
on change order/contract amendment activities.
? Review, approve and follow up on project invoices.
? Working with Company functional department leads, determine and manage project resource needs and utilization according to project
contract and contract amendments.
? Communicate and coordinate project timelines for all required project functional service areas, client and third party vendors, as
required.
? Plan, participate and present at investigator meetings, as required.
? Plan and lead client meetings and project team training sessions.
? Accountable for developing and maintaining project metrics, timelines and deliverables.
? Lead internal team, client and other project related teleconferences and meetings (may include agenda and meeting minutes
preparation/review.)
? Communicate expectations for roles and responsibilities to assigned project team members and ensure those expectations are
fulfilled.
? Ensure project documentation is complete, current, stored appropriately and audit?ready.
? Function as primary liaison between client, third party vendors as warranted and Company project team for project issues, including
initiation, planning, execution and close?out of assigned studies.
? Proactively communicate to appropriate Company management, client and third party vendors as warranted about project progress,
potential issues and appropriate recommendations for issues resolution.
? Participate in business development activities as required.
? May participate in Company task force initiatives.
? Present at both industry and internal meetings.
? May serve as project management leader for assigned clients with management oversight responsibilities for client’s active projects.
? If applicable: Train, mentor, support and provide leadership to direct reports and assigned project teams.
? If applicable: Supervise, mentor, provide feedback and career development opportunities for assigned direct reports.
? If applicable: Coordinate, write and deliver performance management activities for assigned direct reports.
? If applicable: Perform other duties as assigned by management.

公司介绍

Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, global CROs. Theorem provides core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics.

So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:

?    Project Management
?    Clinical Monitoring*
?    Clinical Data Management*
?    Regulatory Affairs*
?    Clinical Quality Assurance
?    Safety Surveillance/Pharmacovigilance*
?    Biometrics*
?    Clinical Writing
?    Investigator Agreements
?    Medical Affairs
?    Patient Recruitment

The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.

Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.