Associate Feasibility Manager - Anywhere US

Company
Synteract
Location
United States
Salary
Competitive
Posted
15 Feb 2021
Closes
17 Mar 2021
Ref
28972
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Associate Feasibility Manager - Anywhere, US

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

As an Associate Feasibility Manager you will team with a Feasibility Manager and assist 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:

  • Assists in Study Review - Review clinical protocols, study assumptions, client information and study plans for US and global trials.
  • Assists to 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.
  • Assists in the design of 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.
  • May provide input to proposals and business development to help build project assumptions, budget, and timelines.
  • May participate in strategy meetings with internal and external groups.
  • Provide feasibility reports and feasibility presentations.
  • May 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 3 years applicable industry experience or equivalent combination of education and experience

Specific Knowledge
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations
  • Proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
  • Effective verbal and writing skills; English + local language, if relevant.

This job excludes Colorado applicants.

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. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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