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!
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.
• 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
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
USA-North Carolina-Research Triangle Park
USA02 - US Clinical Development Svcs
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