Global Feasibility Lead, US

TSSU – Clinical Planning and Analytics team has an exciting opportunity for a Global Feasibility Lead.

The Global Feasibility Lead will perform, manage and coordinate activities associated with feasibility for assigned opportunities/ projects. Analyze data and present to internal stakeholders together with recommendations. Train and mentor junior staff.

Responsibilities:

  • Accountable for making recommendations for Quintiles commitments for future studies in terms of recruitment rate, timelines and screen failure rates
  • Take independent responsibility for complex feasibilities projects / deliverables
  • Prepare for strategy calls by research into therapeutic areas using internal databases, scientific literature, the Internet and expert medical knowledge to provide background information
  • Attend strategy calls with internal stakeholders including Medical Directors and Advisors, Business Developers, Sales Staff and Program Directors. Present background information, particularly including country recruitment and screen failure data
  • Design of protocol-specific questionnaires for collection of global feasibility information for individual countries and sites in order to determine patient populations and protocol suitability
  • Develop feasibility analysis systems and data collection tools in Excel to support the collection of associated metrics
  • Provide appropriate tools for country feasibility leads to carry out feasibility and capability exercises e.g. telephone training and detailed emails
  • Coordinate the collection and analysis of global feasibility information to meet the challenging timelines of the proposal process and independent feasibility assessments
  • Reconcile and interpret feasibility data, providing solid recommendations and scenario planning as required
  • Production of feasibility text for proposals and feasibility reports
  • Review budgets for stand-alone paid feasibility studies
  • Train and support new team members
  • Perform training for new country feasibility staff
  • Attend client meetings as required to present feasibility process and explain recommendations
  • Liaise with internal and external customers globally to coordinate the collection and delivery of feasibility data
  • Maintain and update departmental information repositories and databases
  • Undertake therapeutic training, as necessary, and keep abreast of developments in clinical research generally

Bachelor’s degree in life sciences or related field, with 5 years’ relevant experience including demonstrable experience in acting as the main regional lead in studies or equivalent combination of education, training and experience.

  • Clinical/project management experience is preferred
  • General knowledge and understanding of company clinical systems, procedures and corporate standards
  • Good knowledge of medical terminology, GCP, FDA regulations, and Drug Development process
  • In-depth understanding of clinical research
  • Excellent communication, organizational and interpersonal skills
  • Fluid report writing in English
  • Strong computer literacy, including well-developed computer skills in applicable software
  • Ability to work independently and effectively prioritize tasks

EEO Minorities/Females/Protected Veterans/Disabled


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