Study Start-Up Specialist 1, IQVIA Biotech, Poland

Study Start-Up Specialist / Regulatory & Start-Up Specialist

IQVIA Biotech

Poland

Homebased

At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies.

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.

Essential Functions

• As a Study Start-Up Specialist, you will work with projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.

• You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.

• You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.

• You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.

• Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.

Qualifications and Skills

• Bachelor's Degree Bachelor’s Degree in life sciences or a related field

• 1 - 2 years clinical research experience in study start-up and feasibility

• Experience of Essential Document Package (EDP) compilation essential.

• Good knowledge of regulatory submissions for Europe

• EUCTR knowledge

• In-depth knowledge of clinical systems, procedures, and corporate standards.

• Good negotiating and communication skills with ability to challenge, if applicable.

• Effective communication, organizational, and interpersonal skills.

• Ability to work independently and to effectively prioritize tasks.

• Ability to manage multiple projects.

• 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.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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.