BrightOwl Loader Loading

Clinical Development Officer - China  

Company managed [?] Still accepting applications
4 Facebook  Linkedin

Posted on : 13 May 2017

Project Description

Clinical Development Officer


Business Development
  • Identify, screen, evaluate and develop investigators for clinical trial participation
  • Develop and maintain relationships with major institutions
  • Develop new sites
  • Provide input to study manager on protocol and enrollment feasibility for studies
  • Partner with study manager on the design and contribute to the strategy of clinical study protocols
  • Attend key therapeutic meetings, departmental education/business updates and other forms of technical and non-technical training
  • Maintain technical expertise within a therapeutic area to engage in scientific discussions with the investigator and institution personnel
  • Support Country Study Manager (CSM) on Final Patient Allocation (FPA) process
  • Negotiate budgets and contracts with institutions and investigators with an emphasis on usage of standard agreements and Fair Market Value (FMV)

Business Management
  • Primary interface with investigators
  • Manage the link between site and the Third Party Organization (TPO)
  • Single point of contact for institutions to identify and resolve business process barriers
  • Drive key/critical site level patient allocation
  • Responsible for site specific enrollement and first patient visit
  • Interact and influence the development and implementation of site initiation/enrollment risk plans for clinical trials
  • Collaborate with Lilly partners, Quality, and other study team members to resolve/escalate site specific issues when necessary
  • Effectively understand and use resources to resolve investigator needs
  • Apply broad clinical research knowledge to impact strategy and process
  • Understanding of drivers that run the business and how other areas of the business are affected
  • Leverage strategic knowledge of institution’s decision making process and deliver mutually acceptable business solutions
  • If applicable, involvement/oversight of fully outsourced trials

External Influence
  • Develop and maintain relationships with major therapeutic institutions
  • Maintain active relationships and/or memberships with applicable research and disease-state organizations
  • Influence and challenge internal and external environmental factors that impact clinical research strategy

Communication/Information Management
  • Serve as primary point of contact for site personnel relative to business related issues
  • Actively listen and respond to customer needs
  • Serve as an effective communication “bridge” between our customer/partners and Lilly
  • Coordinate, communicate, develop best practices, and build relationships using cross-functional teamwork

  • Responsible for understanding and complying with all regulatory requirements
  • Responsibilities include understanding and following all compliance, procurement, legal, financial and Global Medical Standards and Procedures
  • Maintain familiarity with regulations and guidelines regarding patient enrollment practices
  • Responsible for the initiation and evaluation of Anit-Corruption Due Diligence (ACDD) with inverstigators
  • Provide audit and inspection support

Minimum Qualification Requirements:

  • Demonstrated success in effective interpersonal and communication skills
  • Demonstrated strong leadership, teamwork, and influence are necessary
  • Experience in professional networking with positive mutually beneficial outcomes
  • Demonstrated negotiation skills
  • Strong medical knowledge in the respective therapeutic area
  • Strong problem-solving skills, including stractegic and creative thinking
  • Experience and success in self-managing priorities and multi-tasking projects
  • Travel required
  • Excelllent oral and written communication skills
  • Fluent in English

Other Information/Additional Preferences:

  • Bachelor’s degree or equivalent work experience in a scientific or health-related field
  • Preferably at least 2 years previous work experience in Clinical Trial/Development experience and good working knowledge of Clinical Research Process
  • Computer skills (e.g. Excel, Word, PowerPoint).