Junior Study Start-Up Specialist (m/w/d), Home Office - #10516817

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

In this role you will perform tasks at a country level (Germany and/or Austria) 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 contracting and budget negotiations or in the field regulatory submissions, a combination is possible as well.

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.
• Review, prepare and negotiate site contracts and budgets with sites. Prepare site regulatory documents, reviewing for completeness and accuracy. Perform quality control of documents provided by sites.
• 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 1 years of clinical research experience, preferable in study start-up, alternatively an equivalent combination of education, training and experience.
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Fluent language skills in German (on at least C1 level) and 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.
• Flexible working schedule and home-office.
• Competitive salary, bonus system, pension and more.
  
  

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

We invite you to join IQVIA.

Please apply with your English CV, motivation letter and your certificates and reference letters.

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 https://jobs.iqvia.com