Job Title: Regulatory and Start-Up Specialist 1
Location: Frankfurth, Germany
 

Job Overview:
The Regulatory and Start-Up Specialist 1 is responsible for supporting the site identification process and performing regulatory start-up and maintenance activities in accordance with regulations SOPs and project requirements at the global regional or country level. This role involves preparing and managing site regulatory documentation reviewing and negotiating site regulatory documents and contracts with sites and sponsors maintaining reviewing and reporting on site performance metrics serving as the primary point of contact for investigative sites tracking completion of regulatory and contractual documents for sites ensuring contracts are fully executed and establishing project timelines.
 

IQVIA Overview:
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. Our work accelerates the development and commercialization of medical treatments that improve patient outcomes and population health worldwide. IQVIA’s global team of 88000+ professionals spans more than 100 countries supporting clinical research at every scale. As the world’s largest clinical trial site network and CRA footprint we empower our clinical teams to work confidently collaboratively and globally.
 

Responsibilities:

• Manage and execute the site identification process and perform regulatory start-up and maintenance activities in accordance with regulations SOPs and project requirements.
• Prepare and manage site regulatory documentation.
• Review and negotiate site regulatory documents and contracts with sites and sponsors.
• Maintain review and report on site performance metrics.
• Serve as the primary point of contact for investigative sites.
• Track completion of regulatory and contractual documents for sites.
• Ensure contracts are fully executed.
• Establish project timelines.
• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations SOPs project requirements and contractual/budgetary guidelines.
• 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 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 plans as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review track and follow up on the progress 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 ongoing project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.
   

Qualifications:

• High School Diploma or equivalent.
• Previous experience in regulatory and start-up activities.
• Knowledge of applicable regulations and compliance requirements.
• German language fluency

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.