Description
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 are searching for a Sr. Feasibility Specialist to
join our team in Research Triangle Park, North Carolina or Reading,
United Kingdom!.See https://quintiles.taleo.net/careersection/10080/jobdetail.ftl
This position can be office-based or home-based.
PURPOSEPerform,
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
• 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.
• 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.
Qualifications
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES• Clinical/project management experience is preferred.
• General knowledge and understanding of company clinical systems, procedures and corporate standards.
• Thorough knowledge of medical terminology, GCP, FDA regulations, and Drug Development process.
• In-depth understanding of clinical research.
• Hands-on experience of Feasibility.
• 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 5 years’ related experience in clinical research; or equivalent combination of education, training and experience.
• General knowledge and understanding of company clinical systems, procedures and corporate standards.
• Thorough knowledge of medical terminology, GCP, FDA regulations, and Drug Development process.
• In-depth understanding of clinical research.
• Hands-on experience of Feasibility.
• 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 5 years’ related experience in clinical research; or equivalent combination of education, training and experience.
0 comments:
Post a Comment