Regulatory & Start Up Specialist I, Iqvia Medtech, Austria

vor 6 Stunden

Wien, Österreich IQVIA Vollzeit

Vienna, Austria | Full time | Home-based | R1512196

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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