(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 o…
Job objective To provide QA leadership and oversight for GMP audit activities, including the establishment and maintenance of a risk-based audit strategy; training and continuous development of GMP auditors, within a mat…
Job Description Summary -The Sales Representative is a leading driver of our customer interactions and sales performance. They are the face of our customer experience approach and build deep relationships that deliver va…
Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize…
Skills: Computer System Validation, GxP Regulations, 21 CFR Part 11, Data Integrity Risk Assessment, GAMP5
At Incision (www.incision.care), our mission is to revolutionize surgical training and ensure that every patient receives the best possible care. We collaborate with surgical professionals and teams worldwide, sharing ex…
Skills: Data entry, Data accuracy, Attention to detail, Organizational skills, Time management
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
bachelor degree
Supportive Leaders, Mentors, Career Growth Resources, Flexible Working Schedule, Home-office, Competitive Salary
Posted 35d ago
~40 hrs/week
Responsibilities
The role involves managing clinical research site activation activities, including negotiating contracts and budgets and preparing regulatory documents. The specialist serves as the primary point of contact for investigative sites and ensures adherence to SOPs and project timelines.
Requirements
A university degree in life sciences or a healthcare apprenticeship is required, along with clinical research experience in study start-up. Candidates must be fluent in Arabic and English and possess knowledge of GCP and ICH guidelines.
Full job description
(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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US