Associate Site Manager with Italian and English language

Employer
IQVIA
Location
Bucharest
Start date
21 Nov 2022
Closing date
21 Dec 2022

View more

Discipline
Operations, Site services
Hours
Full Time
Contract Type
Permanent
Experience Level
Entry level
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Job Details

Job Overview

Under the direction and guidance of the Real-World Late Phase Research Clinical Operations Lead, Line Manager or Project Manager, conduct clinical remote monitoring visits and other clinical research activities in accordance with Study Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (ICH GCP) and applicable regulatory requirements. Gain an understanding of all aspects of Real-World Late Phase Research, Site Management and Site Monitoring.

RESPONSIBILITIES

  • Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites.
  • Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
  • Perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs, and work instructions.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Operations Lead (COL) and/or Line Manager.
  • Manage and follow study activities through ongoing tracking and review of study progress. Report progress to Line Management and Project team.
  • Manage the progress of assigned studies by documenting recruitment and enrolment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
  • Gain experience with standard IQVIA tools, metrics, and reports.
REQUIREMENTS
  • Bachelor’s Degree in Life Science, Health science or Pharmacy, is a must.
  • Prior relevant experience will be an asset.
  • ​Excellent written and verbal communication skills including good command of English & Italian language.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
  • Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is preferred.
  • Organizational, planning, interpersonal, and problem-solving skills.
  • Strong attention to detail.
  • Time management skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites.

What is in it for you?

  • Global exposure
  • Variety of therapeutic areas
  • Collaborative and supportive team environment
  • Access to cutting-edge in-house technology
  • Excellent career development and progression opportunities
  • Work-Life Balance

JOIN US!

  • Embrace your curiosity and grow your career in an exciting environment where development is a priority.
  • Think boldly and disrupt conventional thinking.
  • Enjoy what you do.

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.

IQVIA-icon-hubPlease visit our Careers Hub on

https://www.pharmiweb.jobs/minisites/iqvia-careers-hub-/

 

 

 

Find Us
Website
Telephone
866-267-4479
Location
4820 Emperor Blvd
Durham
Wake
27703
GB
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