(Sr) Site Activation Specialist

Locations: New Cairo, Egypt
Work Model: Hybrid

IQVIA currently offers the exciting opportunity for a(Sr.) Site Activation Specialist to work in the Country Site Activation Department in our New Cairo office in Egypt.

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.

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 inlife science or other scientific discipline or apprenticeship in health care.

• 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 Arabicand 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 and more.

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

Please apply with your English CV.