- Accountable for making recommendations for Quintiles commitments for future studies in terms of recruitment rate,
timelines and screen failure rates
- Take independent responsibility for capability exercises and larger 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 to internal stakeholders
- Production of feasibility text for proposals and feasibility reports
- Review budgets for stand-alone paid feasibility studies
- Train and support new team members
- 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
- 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree in Healthcare or Biological Science and a minimum of 3 years related experience in clinical research;
or equivalent combination of education, training and experience
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