Site Activation Specialist
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Key skills for this role
About the Role
IQVIA seeks a Site Activation Specialist to manage clinical research site activation activities in Dubai. The role involves regulatory submissions, contract negotiation, and project coordination.
Key Skills for This Role
Responsibilities
- Serve as Single Point of Contact for investigative sites, RSU Team Lead, Clinical Operations, and clients
- Ensure adherence to SOPs, work instructions, quality of deliverables, and project timelines
- Perform regulatory, start up, and maintenance activities per regulations and SOPs
- Review, prepare, and negotiate site contracts and budgets
- Prepare and submit approval documents to regulatory and ethical committees
- Track progress and execution of documents including contracts and regulatory approvals
- Maintain internal systems, databases, and tracking tools
- Review and provide feedback on site performance metrics
Requirements
- University degree in life science or other scientific discipline or apprenticeship in health care
- Clinical research experience, preferably in study start up
- Knowledge of GCP and ICH guidelines
- Fluent in Arabic and good command of English
- Strong written and verbal communication skills
- Attention to detail and ability to multitask
Full Job Posting
Overview
- IQVIA offers an exciting opportunity for a (Sr.) Site Activation Specialist to work in the Country Site Activation Department in Dubai office in UAE.
- Perform tasks at a country level associated with clinical research site activation activities in accordance with applicable regulations, SOPs, 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 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.
Application Notes
- Please apply with your English CV.
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
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