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Local Study Associate Director / Clinical Project Manager

Employer
IQVIA
Location
Reading
Start date
4 Jan 2023
Closing date
2 Feb 2023

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

The Role

The Local Study Associate Director / Clinical Project Manager will lead Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with the Sponsors' procedural documents. This is a fully remote role, with very minimal travel required to cover or assist CRA in other monitoring visits if required.

Responsibilities

  • Leads the performance of the Local Study Team at country level
  • Ensures clinical and operational feasibility assessment of studies is performed to the highest quality.
  • Coordinates the site selection process by identifying potential sites
  • Performs initial Site Quality Risk Assessment
  • Ensures timely submission of application/documents to EC/IRB at start up Ensures timely preparation of country financial Study Management Agreement Plans and coordinates applicable local drug activities (from local purchase to drug destruction).
  • Reviews monitoring visit reports
  • Organizes regular Local Study Team meetings on an agenda driven basis
  • Develops, maintains and reviews risk management plan on country study level: Communicates and co-ordinates regularly with National Co-ordinating
  • Plans and leads National Investigator meetings, in line with local codes
  • Participates in training and coaching new members of the Local Study Team
  • Ensures completeness of the eTMF
  • Plans and leads activities associated with audits and regulatory inspections
  • Ensures compliance with Code of Ethics
  • Collaborates with local Medical Affairs team.

Qualifications

  • Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
  • Minimum 3 years of experience in Development Operations (CRA, SCRA) or other related fields (Medical Affairs-led or Academic-led studies).
  • Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
  • Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
  • Excellent project management skills.
  • Excellent team building and interpersonal skills.
  • Good negotiation skills.
  • Good medical knowledge and ability to learn relevant Therapeutic Areas.
  • Excellent understanding of the Clinical Study Process including monitoring.
  • Good resource management skills.

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

Company

At IQVIA™, we are committed to advancing human health and delivering real value and outcomes for customers and patients. We view each day as another opportunity to find new solutions and enable the next breakthrough.

IQVIA is a leading global provider of information, innovative technology solutions and contract research services dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 55,000 employees worldwide.

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Find Us
Website
Mini-site
IQVIA
Telephone
866-267-4479
Location
4820 Emperor Blvd
Durham
Wake
27703
United Kingdom
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