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Job Details

Feasibility Manager

Company: SynteractHCR Deutschland GmbH
Location: Morrisville, NC
Reference: 27072
Closing Date: 27 May 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

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.

Requirements:

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. This position can be based in Morrisville, NC, Carlsbad, CA or Remote, Anywhere US.

 

Responsibilities

  • 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

Academic & Professional Qualifications:

  • Bachelor/Masterdegreein arelatedfieldof studyandaminimumof5 years applicableindustryexperienceorequivalentcombinationof educationand experience.

  • SomeexperienceasanResearchSpecialist,FM, PM, CRA orCTA isrequired.

  • A minimumof 3 yearsexperiencein the conductof clinicaltrialsisrequired.

Skills & Experience:

  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.

  • Proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.

  • Strong verbal and writing skills; English + local language, if relevant.

 

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

SynteractHCR’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 SynteractHCR 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.


Apply for this job: Feasibility Manager

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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