Study Start Up Specialist, Fluent in Danish, IQVIA Biotech - Home-based in Denmark

Review and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets. This will be done with consultation from the regulatory lead and contracts lead regionally.

Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.

Review and provide feedback to SSU manager on site performance metrics.

Work with regulatory team members and SSU manager to secure authorization of regulatory documents.

Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned country.

Responsible for the translation and co-ordination of translations for documents required for submission.

Responsible for liaising with local CRA/CTM, Contract Specialist, and Regulatory Lead to enable a rapid clinical trial start up.

Work with legal team members and SSU Manager to secure authorization of contracts.

Inform team members of completion of regulatory and contractual documents for individual sites.

May participate in feasibility and/or site identification activities.

Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.

Collects and reviews initial regulatory packets and site contracts for investigator sites.

Assures that SSU functions interface effectively with all other key operating departments within IQVIA Biotech. Working with Clinical Operations, Project Management, Site Identification, additional SSU specialists, Regulatory and Contracts group on SSU project specific status and deliverables.

Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.

Create, review and customization of country/site specific Informed Consent Forms (ICFs).

Participates in business development activities to grow IQVIA Biotech’s business.

Facilitates process improvement efforts both within the department and in cooperation with other departments.

Fluent in reading and writing in the Danish language

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.

Have extensive knowledge and understanding of submissions experience in Polish.

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.

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.