22 feb
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Estado de México
Job Title: Senior Study Site Specialist Location: UK, Poland, Spain, Romania, Bulgaria, and Serbia Sponsor: Dedicated As a Senior Study Site Specialist, you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Working fully embedded within an ever-expanding program that specializes in the Oncology space, you will be responsible for conducting end-to-end site start-up from feasibility to site closure, serving as the primary point of contact for the site, country, and the study team.
Additional Responsibilities Include: Participate in study-specific site management meetings.
Utilize tools to track activities and develop reports.
Responsible for essential document collection, tracking & review.
Responsible for the collection of country and site level intelligence.
Responsible for Institutional Review Board/Ethics Committee submissions for the country.
Support Regulatory Authority submissions.
Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.)
required to activate sites for a study as appropriate.
Manage site-level Regulatory Green Light processing.
May serve as an In-House Study Lead on limited-scope studies, a primary point of contact to study team on end-to-end study activity.
Lead study-specific site management meetings as appropriate.
Oversee essential document collection, tracking & review.
To be successful in this role, you must have: Preferred BA/BS degree in Business Administration, science, or related field, or additional relevant experience.
At least 5 years of relevant experience in the biopharmaceutical/CRO industry.
Strong presentation,
documentation, and interpersonal skills.
Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
Ability to handle multiple tasks to meet deadlines, delivering high-quality work in a dynamic environment.
Excellent oral and written communication skills.
Thorough understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
Thorough understanding of FDA and/or EU Directives and Regulations, ICH Guidelines, and various country/local regulatory requirements.
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
What ICON can offer you: Our success depends on the quality of our people.
That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
Benefits Examples Include: Various annual leave entitlements.
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over independent specialized professionals who are there to support you and your family's well-being.
Life assurance.
Flexible country-specific optional benefits, including childcare vouchers,
bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers website to read more about the benefits of working at ICON: At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
We're proud of our diverse workforce and the work we've done to become a more inclusive organization.
We're dedicated to providing an inclusive and accessible environment for all candidates.
ICON is committed to providing a workplace free of discrimination and harassment.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,
national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below: Interested in the role, but unsure if you meet all of the requirements?
We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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