Regulatory and Start Up Specialist - Switzerland

IQVIA; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Site Activation professional to manage country-level site activation activities (SA) and related regulatory/document tasks. The role emphasizes working under SOPs, WIs, and project timelines, with focus on accuracy of regulatory materials and timely site activation.

Requirements include a Bachelor’s degree in life sciences and at least 3 years in clinical research or related fields, plus thorough knowledge of GCP/ICH and local regulatory guidelines.

Qualifikationen

• Bachelor’s Degree in life sciences or a related field.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.

Aufgaben

• Serve as Single Point of Contact (SPOC) for investigative sites, SAM, PM team and other departments.
• Ensure adherence to SOPs, WIs, quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to regulations and SOPs.
• Prepare site regulatory documents and review for completeness and accuracy.
• Maintain internal systems and databases with project-specific information.
• Review project timelines and ensure monitoring measures are in place.

Kenntnisse

GCP/ICH knowledge

Regulatory knowledge

Project coordination

Ausbildung

Bachelor’s degree in life sciences or related field

Jobbeschreibung

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 position requiring German 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.

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.

IQVIA 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.

EEO Minorities/Females/Protected Veterans/Disabled