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Posted 2d ago

Regulatory and Start Up Specialist - Poland

@ IQVIA
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Warsaw, Poland, Poland
zł147k-zł273k/yrRemoteFull Time
Responsibilities:serve SPOC, perform activation, prepare documents
Requirements Summary:Bachelor’s degree in life sciences or related field; 3 years clinical research or related experience; knowledge of GCP/ICH and regulatory guidelines; experience with site activation and regulatory documents.
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Job Description

Regulatory and Start Up Specialist

Poland - Homebased
Fixed Term Contract


Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Home Based opportunity that requires Polish language fluency.
 

Essential Functions

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines.
  • Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

Qualifications
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.


 

If you’re passionate about driving excellence in clinical trial contracting and want to make an impact across global programs, we encourage you to apply!


The potential base pay range for this role, when annualized, is 146, 800 zł - 272, 500 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł102 800,00 - zł272 500,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.