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Senior Project Set-Up Coordinator

Location: Durham, North Carolina; Indianapolis, Indiana; Ithaca, New York; Marietta, Georgia
R1325311

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As a member of our global Set-Up team, you will play a vital role in the design and launch of clinical trials, collaborating with cross-functional colleagues around the world to exceed expectations. From your first day at Q2 Solutions, you will have a chance to cultivate the behaviors, knowledge and skills needed for you to be successful. You will have the opportunity to grow and develop your career, while partnering with top pharmaceutical companies, CROs, specialty, local and third-party labs and medical device manufacturers on complex clinical trials.

  • Full Time
  • Level: Mid-level
  • Travel: No

Success profile

What makes employees on our Set-Up team successful? Check out the top traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Communicator
  • Leadership
  • Strategic
  • Problem solver
  • Relationship building

Career path

As you progress through your career at Q2 Solutions, you'll play an important part in helping our customers drive healthcare forward and ultimately improving health outcomes for patients.

  1. Laboratory Project Set-Up Coordinator
  2. Senior Laboratory Project Set-Up Coordinator
  3. Associate Laboratory Project Set-Up Manager
  4. Laboratory Project Set-Up Manager
  5. Senior Laboratory Project Set-Up Manager

Quote

“I know Q2 Solutions offers me a great career path with lots of options. My line manager fully supports my growth.”

Marianne H., Associate Laboratory Project Set-Up Manager

A career at Q2 Solutions will provide...

  • Professional Development

    Resources that promote your career growth

  • Flexibility

    Work culture that supports improved work-life balance

  • Variety

    Dynamic work enviroment that exposes you to new experiences

  • Growth Potential

    Clear pathways to success

  • Collaboration

    Cross-functional idea sharing and thinking to accomplish common goals

Senior Project Set-Up Coordinator

Apply now
Location: Durham, North Carolina, United States R1325311

Job description

Job Overview

Provide project related support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System(s); ensure work is conducted in line with standard operating procedures, policies and good practice. Accountability and ownership for the quality of database configuration.

Essential Functions

  • Assist with study validation activities
  • Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements
  • Configure project database, where applicable
  • Maintain accurate project documentation files
  • Keep Setup Managers, Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project
  • Coordinate meetings with relevant colleagues and internal departments (e.g. planning and handover meetings)
  • Participate in local and global improvement projects as defined by the relevant process improvement management team
  • Participate in internal audits, as required
  • Communicate with study Sponsor(s) as needed (e.g. exchanging factual information)
  • Assist in the development of database design requirements for protocols and protocol amendments
  • Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues
  • Manage the set-up process for a low complexity study, where applicable. Mentor and assist in training more junior staff
  • Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications

  • High School Diploma or equivalent  Req And
  • Bachelor's Degree Life Sciences or related field Pref
  • Minimum 1 year relevant experience in the Clinical, Medical or Healthcare industry.
  • r equivalent combination of education, training and experience.
  • Posses strong organizational and coordination skills.
  • Proven track record of quality, accuracy and attention to detail.
  • Good written and verbal communication skills including good command of English language.
  • Computer proficiency in word processing and spreadsheet applications.
  • Posses enhanced technical and operational knowledge, especially in the area of Clinical Trial Management Systems (preferred).
  • Demonstrated ability to work in a fast-paced environment.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients.
  • Knowledge of Laboratory processes and computer systems helpful.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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