Reg & Start Up Spec 2

IQVIA; Warszawa; On-site; PLN 151,000 - 281,000; Full time

Job summary

IQVIA in Poland seeks a Site Activation specialist to manage country-level SA activities under SOPs and regulatory guidelines. You will act as the SPOC for sites, SAMs, and PM teams, ensuring timely activation and document quality.

You will review regulatory documents, maintain tracking tools, and support project timelines with contingency planning, liaising with sponsors when required.

Qualifications

• Bachelor's Degree in life sciences; 3 years clinical research or related experience.
• Experience leading in a project environment is preferred.
• Knowledge of GCP/ICH and regulatory guidelines.

Responsibilities

• Serve as SPOC for investigative sites, SAM, PM team and other departments.
• Perform site activation activities and distribute documents to sites and team.
• Prepare and review site regulatory documents for completeness.
• Maintain internal systems and tracking tools with project data.
• Provide feedback on site performance metrics and timelines.
• Plan project timelines, monitoring measures and contingency actions.
• Coordinate regulatory and IP release documents within timelines.
• Support SAMs and project teams in timeline planning.
• Perform quality control of documents provided by sites.
• Interact with sponsors on specific initiatives when needed.

Skills

Leadership experience

Negotiation

Communication

Organizational skills

Prioritization

Education

Bachelor's Degree in life sciences

Job description

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

• Bachelor's Degree 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.
• 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
• 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 zł151,200.00 - zł280,700.00. 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.