Clinical Lead

Remote, Remote
Full Time
Product
Posted on: October 29, 2022

Position Highlights

Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study start-up through study close-out activities and Clinical Study Report (CSR). Work with US local study team, with internal and external partners, on local studies across different phases of drug development and different therapy areas.

Typical Accountabilities

  • Coordinate operational aspects of Sponsored studies from Study start-up through CSR/Publication.
  • Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
  • Interface with field monitoring CRAs, Local Study Manager (LSM) and global study team (GST)
  • Establish and maintain interactions with key stakeholders including the facilitation of communications with GST, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives
  • Implement globally agreed Development Operations strategies including processes and use of technical systems related to Operations
  • Contribute to the development of Operations documents as appropriate as well as any updates/amendments to those documents
  • Ensure timely entry and/or update appropriate information into sponsor tracking and communication tools (e.g. IMPACT)
  • Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate
  • Contribute to the planning and conduct of any local internal and external meetings (e.g. Investigator/Monitors meeting)
  • Monitor study conduct and progress, proactively identifying and resolving with the LSM issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives
  • Contribute to steering committees, submission assembly teams, regulatory defense teams, and Advisory Boards as necessary
  • Contribute to ad hoc team productivity and efficiency by providing direction and facilitating good team dynamics
  • Provide input into non-drug project work including training activities, and development of procedures as needed

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-statusv

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Clinical Lead

IQVIA

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