Clinical Research Associate II (R1123669) in Paris, FR at IQVIA™

Date Posted: 3/18/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Paris, FR
  • Experience:
    Not Specified
  • Date Posted:
    3/18/2020
  • Job ID:
    R1123669

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

RESPONSIBILITIES:

Study Planning

  • Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
  • Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators.
  • Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
  • Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure adherence to payment schedule.

    Study Start-up

  • Execute site initiation and training, generate initiation visit report.

    Study Execution

  • Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
  • Identify problems at sites; resolve issues and escalate as appropriate.
  • Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
  • Complete preparation and generation of visit monitoring reports as per relevant SOP
  • Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
  • If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues

    Study Close-out

  • Implement site close-out activities and generate site close-out report.
  • Provide feedback on site performance for future trial site feasibility/selection

    General

  • Improve skills by timely completion performance of assigned global and local training.
  • REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
    • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Strong therapeutic and protocol knowledge as provided in company training
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
    • Strong written and verbal communication skills including good command of English language
    • Strong organizational and problem-solving skills
    • Effective time management skills
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in a health care or other scientific discipline or educational equivalent and 1 year of on-site monitoring experience; or equivalent combination of education, training and experience

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1123669