Feasibility Manager
Quintiles Transnational - Research Triangle Park, NC
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We have a rewarding opportunity for a Feasibility Manager!

PURPOSE

Perform, manage and co-ordinate activities associated with feasibility for complex opportunities/ projects. Collate data and present to internal stakeholders together with recommendations. Train and mentor junior staff and country leads.

RESPONSIBILITIES
Accountable for making recommendations for Quintiles commitments for future studies in terms of recruitment rate, timelines and screen failure rates
• Represent department at internal meetings with other functions
• Proactively identify ways to improve process and work with key customers on future processes
• Evaluate external tools and vendors for suitability and relevance to Feasibility process
• Take independent responsibility for complex feasibility 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
          Qualifications
          REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
          • Strong interpersonal skills.
          • In depth knowledge of the drug development processes across all functional areas
          • Ability to understand, access, and analyze data from divergent sources to provide an assimilation of data leading to conclusions and recommendations.
          • Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines
          • Knowledge of clinical research financial parameters and project financial tracking and accounting methods
          • Effective presentation skills
          • Computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word, and Excel.
          • Good written and verbal communication skills including good command of English
          • Excellent organizational and problem solving skills
          • Effective time management skills and ability to manage competing priorities
          • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

          MINIMUM REQUIRED EDUCATION AND EXPERIENCE
          Bachelor's degree in life sciences or related field with 7 years’ relevant experience including demonstrable experience in an international role; or equivalent combination of education, training and experience.

          EEO Minorities/Females/Protected Veterans/Disabled

          Primary Location : USA-North Carolina-Research Triangle Park

          Organization : USA02 - US Clinical Development Svcs

          Quintiles Transnational - 27 days ago - save job - block
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          About this company
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          Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...