Senior Site Activation Specialist

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $1G Post-IPO Debt on 2023-05

Healthcare Insurance • Biotechnology • Artificial Intelligence

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• 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.

🎯 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.