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(senior) Feasibility Manager

Company: Synteract
Location: New York
Posted on: August 17, 2019

Job Description:

(Senior) Feasibility Manager SynteractNew York City, NY, US 22 hours agoBe among the first 25 applicants Apply on company website (Senior) Feasibility Manager - Anywhere, US Office-based or Remote-based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of Bringing Clinical Trials to Life, we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. 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. Please note that this position is open for the purpose of future needs recruitment and we are looking to start the initial conversations. 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 B ach e lo r / M as t e r deg r e e i n a r ela t e d f i el d o f s t ud y a n d a mi n im u m o f 2 y ea rs app l ic a bl e in d us try e x pe r ie n c e o r eq u i v al e n t c om b ina t io n o f e duc a t io n an d e x pe r ience . Some experience as an Research Specialist, FM, PM, CRA or CTA is required A minimum of 2 years experience in the conduct of clinical trials is required. Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, Outlook. Effective verbal and writing skills; English + local language, if relevant 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. Seniority level Associate Employment type Full-time Job function Other Industries BiotechnologyHospital & Health CarePharmaceuticals Similar jobs

Keywords: Synteract, New York , (senior) Feasibility Manager, Executive , New York, New York

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