Feasibility Manager - Remote, Europe

Company
Synteract
Location
United Kingdom
Salary
Competitive
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
28836
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Feasibility Manager - Europe

Remote

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. With our mission of Bringing clinical trials to life TM , we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

The Feasibility Manager (FM) is responsible for performing feasibility analysis of clinical trials to assess the study plan and provide feedback and recommendations, including the identification of potential challenges and mitigating strategies. Responsibilities include compiling feasibility reports, presentations, and sample site assessment for investigator feedback on study design and logistics, as well as enrollment potential.

Specific tasks would include

  • Study Review - Review clinical protocols, study assumptions, client information and study plans for US and global trials
  • Research, compile and analyze information on therapeutic area(s) contained in the clinical protocol. This may include any or all of the following: incidence, prevalence, standard of care, factors determining and influencing indication frequency and distribution, treatment trends, competing trials, etc., and use this information to provide an overall assessment of the feasibility of the study plan.
  • Interface with consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
  • Design site surveys/questionnaires to obtain key information (e.g., investigator feedback on projected enrollment, feasibility of the study, and site capabilities); may assist in the identification/selection of sample sites. Oversee the site information collection process and assess compiled information for trends and site capabilities.
  • Provide input to proposals and business development to help build project assumptions, budget, and timelines.
  • Participate in strategy meetings with internal and external groups.
  • Provide feasibility reports and feasibility presentations.
  • Present and explain feasibility analysis to BD/Clients, including the process, recommendations and rationale.


Qualifications
  • Bachelor / Master degree in a related field of study and a minimum of 5 years applicable industry experience or equivalent combination of education and experience.
  • Some experience as an Research Specialist, FM, PM, CRA or CTA is required.
  • A minimum of 3 years experience in the conduct of clinical trials is required.
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.


If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.

#LI-DL1 #LI-REMOTE

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