Specialist or Senior Specialist

vor 7 Monaten

Frankfurt am Main, Deutschland Novasyte Vollzeit

IQVIA currently offers the exciting opportunity as experienced Study Start-Up Specialist / Site Activation Specialist (m/w/d) to work in the Country Site Activation Department in our Frankfurt office or in home office throughout Germany.

In this role you will perform tasks at a country level associated with clinical research site activation activities in accordance with applicable local and/or international regulations, standard operating procedures, project requirements and contractual/budgetary guidelines.

You will be specializing in the field of
_regulatory submissions for clinical trials in Switzerland_.

Your responsibilities might include:

- Serve as Single Point of Contact in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and the client.
- Ensure adherence to standard operating procedures (SOPs), work instructions, quality of designated deliverables and to project timelines.
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Complete and submit approval request documents to Local Regulatory and Ethical Committees. Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Review and provide feedback to management on site performance metrics.

Qualifications:

- University Degree in life science or other scientific discipline or apprenticeship in health care or as legal secretary / paralegal.
- Minimum of 3 years of clinical research experience, preferable in study start-up, alternatively an equivalent combination of education, training and experience.
- Minimum of 2 years experience in the regulatory submissions process in Switzerland.
- Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluent language skills (on at least C1 level) in one of the following languages is a must: German, French, Italian; also a good command of English.
- Strong written and verbal communication skills.
- Attention to detail and ability to work on multiple tasks and prioritize.

What you can expect:

- Supportive leaders, mentors and teams.
- Resources that promote your career growth.
- Dynamic work environments that expose you to new experiences.
- Home-office for some days per week.
- Competitive salary, bonus system and more.

Whatever your career goals, we are here to ensure you get there

We invite you to join IQVIA.

LI-KA1

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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