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IQVIA logo
IQVIA

Accelerate innovation for a healthier world.

Senior Site Activation Specialist

Location

Germany

Posted

2 days ago

Salary

0

Seniority

Senior

Bachelor DegreeGermanEnglishGoogle Cloud Platform

Job Description

Senior Site Activation Specialist

IQVIA

• 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. • 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.

Job Requirements

  • University Degree in life science or other scientific discipline or apprenticeship in health care or as legal secretary / paralegal.
  • 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.

Benefits

  • Flexible working schedule and home-office
  • Competitive salary, bonus system, pension and more.

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