Global Site Feasibility Lead II - Remote (Full-time or Part-time)

Location
Rockville, Maryland
Salary
Competitive
Posted
Oct 20, 2021
Closes
Oct 22, 2021
Ref
2918
Function
Other
Industry
Science
Hours
Full Time
Global Site Feasibility Lead II

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

Responsible for following the appropriate processes for collecting Confidential Disclosure Agreements (CDA) and Feasibility Questionnaires (FQ) from sites. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents-maintained follow International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by Emmes and its clients. A Global Feasibility Lead II may be assigned to one or more start-up projects, and typically is able to work independently on a project with minimal supervision. Project assignments are primarily biopharma.

Responsibilities
  • Accountable for supporting the development, analyses, interpretation, and presentation of primary and secondary data in support of operational strategy and planning
  • Conducts data mining of internal and external databases and initiates/oversees the collection of primary data for use in development of robust strategies for global clinical trials (country/site mix, site selection, enrollment modeling).
  • Participates in the development of proposals and bid defenses; provides recommendations on the most appropriate use of data to support proposals and bid defense presentations, works with the team to identify potential risks, and is learning to propose effective solutions as appropriate
  • Actively participates on cross-functional teams that plan, analyze, and present proposals and bid defenses as part of winning new business and maintaining client base.
  • Serves as functional bidder reviewer of the budget and text for proposals for which feasibility and/or site identification is included as the primary deliverable
  • Leads cross functional teams in standalone feasibility efforts; responsible for final report creation and delivery, including discussion of findings and recommendations with external clients
  • Participates in intra and inter-departmental meetings, leading/contributing to the presentation of information on feasibility offerings, demonstrating continued value-add of the department and providing training on best practices, processes, and tools.
  • Develops networking abilities and has an ability/willingness to work with individuals across the globe.
  • Leads and/or contributes to process improvement or special projects within FSS
  • Lead and/or contributes to development, implementation, and maintenance of systems within FSS
  • Contributes to best practice for feasibility conduct
  • Mentors junior team members (GFS, GFL1 or newer GFL2s as needed)
  • Performs any other duties as assigned

Experience
  • Bachelor's degree in scientific or business field with 7 years' related experience to demonstrate skill proficiency
  • Strong data mining and analytical skills
  • Strong writing and presentation skills
  • Upholds the highest standard of personal professionalism and work integrity
  • Demonstrated ability to work independently
  • Strong attention to detail/quality control skills
  • Ability to successfully and quickly understand scientific information so as to be able to independently source data/information relevant to a scientific/medical strategy
  • Ability to establish and maintain effective working relationships with team members, management, operations staff, clients, and executive management
  • Demonstrated ability to handle multiple competing priorities effectively
  • Negotiation and relationship management skills
  • Experience in analyzing study and investigator performance metric
  • Self-motivated, works effectively under pressure
  • Excellent computer skills, including strong working knowledge of Microsoft Office and other data capture and compilation tools
  • Established knowledge of tools used in obtaining critical market analyses of therapeutic pipelines
  • Strong skills in scientific data manipulation, analysis, reporting and maintenance
  • Proven written and verbal communication skills, with strengths in independently gathering/presenting data in support of operational strategy and planning

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - The Emmes Company, LLC

The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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