Regulatory & Start Up Specialist II, IQVIA MedTech, Poland

IQVIA LLC; Warszawa; On-site; PLN 100,000 - 120,000; Full time

Job summary

A global clinical research firm is seeking a Regulatory & Start Up Specialist II to manage site activation and regulatory activities in Poland. The ideal candidate will have a B Sc in Life Sciences and three years of clinical research experience, with proficiency in Polish. This role requires effective communication, strong organizational skills, and the ability to manage multiple projects while ensuring adherence to regulations and SOPs. Join us in improving patient outcomes and healthcare innovation.

Qualifications

• 3 years’ clinical research experience required.
• In-depth knowledge of clinical systems and procedures.
• Ability to manage multiple projects and prioritize tasks.

Responsibilities

• Serve as Single Point of Contact for assigned studies.
• Ensure adherence to SOPs and project timelines.
• Perform quality control of documents provided by sites.

Skills

Clinical research experience

Polish language proficiency

Negotiating skills

Communication skills

Organizational skills

Education

B Sc Degree in Life Sciences or related field

Job description

Regulatory & Start Up Specialist II, IQVIA MedTech, Poland page is loaded## Regulatory & Start Up Specialist II, IQVIA MedTech, Polandlocations: Warsaw, Polandtime type: Full timeposted on: Posted Todayjob requisition id: R1512176**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*** 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*** B Sc Degree in Life Sciences or related field* 3 years’ clinical research experience* Polish language proficiency is essential for direct communication with the Competent Authority and Ethics Committees.* 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 atIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.