About
The company currently offers the exciting opportunity for a (Sr.) Site Activation Specialist to work in the Country Site Activation Department in our Dubai office in UAE. 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.
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Location
Dubai, United Arab Emirates
Work Model
Hybrid
Responsibilities
- 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, 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 plans 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.
- 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 Arabic 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, and more.
Please apply with your English CV.
