Regulatory and Start Up Specialist 2 Germany mwd Home Based

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

1. 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.
2. Ensure adherence to SOPs, Work Instructions (WIs), quality of designated deliverables, and project timelines.
3. Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
4. Distribute completed documents to sites and internal project team members.
5. Prepare site regulatory documents, reviewing for completeness and accuracy.
6. Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
7. Review and provide feedback to management on site performance metrics.
8. Review, establish, and agree on project planning and timelines. Ensure monitoring measures are in place and implement contingency plans as needed.
9. Inform team members of the completion of regulatory and contractual documents for individual sites.
10. Review, track, and follow up on the progress, approval, and release of documents such as regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) in line with project timelines.
11. Provide local expertise to SAMs and the project team during initial and ongoing project timeline planning.
12. Perform quality control of documents provided by sites.
13. May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor's Degree in life sciences or a related field and 3 years of clinical research 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 standards.
• Understanding of the regulated clinical trial environment and knowledge of the 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 [website].

Required Experience

Unclear seniority level.

Key Skills