Regulatory & Start-Up Specialist
IQIVA Biotech
Homebased
Poland
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
Expertise in EU/local regulatory frameworks.
Proficiency in CTIS submissions, substantial modifications, and amendments.
Deep understanding of EDP processes, site document validation, EC requirements.
Familiarity with CTA budgets and amendment negotiation workflows.
Ability to manage compressed timelines and high RFI volumes.
1 - 3 years’ clinical research experience specifically with regulatory submissions
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 at https://jobs.iqvia.com
The potential base pay range for this role, when annualized, is zł102,800.00 - zł190,900.00. 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.