Regulatory & Start Up Specialist I, Iqvia Medtech, Austria

Vor 4 Tagen

Wien, Österreich IQVIA Vollzeit

**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**

- B Sc Degree in Life Sciences or related field

- 1 - 3 years’ clinical research experience

- German language proficiency is essential for direct communication with the Competent Authority and Ethics Committees.

- Good interpersonal communication and organizational skills.

- Good attention to detail.

- General awareness clinical trial environment and drug development process.

- Ability to work on multiple projects.

- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

- Ability to work independently, to problem-solve collaboratively and to raise issues appropriately as needed.

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