Study Site Management Specialist

ICON Strategic Solutions; United States; Sur place; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Various annual leave entitlements

Health insurance

Competitive retirement planning

Global Employee Assistance Programme (

Life assurance

Flexible country-specific benefits

Résumé du poste

ICON Strategic Solutions is seeking a Site Activation Lead in the United States. You will act as the primary site contact for end-to-end study activity, engage in cross-functional team meetings, and ensure timely delivery of activation milestones across assigned sites and countries.

The role emphasizes proactive issue identification, independent work, and meticulous documentation. Proficiency with Veeva Vault and Microsoft Office is required, with a focus on regulatory submissions and site

Qualifications

• Bachelor’s degree with a minimum of five years of relevant experience in biopharmaceutical/CRO industry.
• Experience in study start-up including ICF activities.
• Flexibility to adjust priorities and workload as needed.
• Able to work independently and proactively identify issues and solutions.
• Detail oriented and able to manage multiple tasks to meet deadlines.
• Proficient with Veeva Vault and Microsoft Office applications.
• Strong interpersonal skills and comfort with ambiguity.

Responsabilités

• Serve as a primary site contact for end-to-end study activity for assigned sites and countries.
• Participate in study site management team meetings and provide updates to cross-functional teams.
• Use systems to track activities and generate reports and metrics as needed.
• Oversee document collection, tracking and review.
• Support collection of country and site level intelligence and regulatory submissions.
• Assist with country/site-specific activities such as import/export licenses and approvals where required.

Connaissances

Attention to detail

Problem solving

Multitasking

Independent work

Interpersonal skills

Adaptability to ambiguity

Communication

Formation

Bachelor’s degree

Outils

Veeva Vault

Microsoft Office

Description du poste

Site Activation Lead
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Be Doing

• Participate in development of in-house model process documents.
• For assigned sites and countries, serve as a primary site contact for end-to-end study activity.
• Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
• Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
• Oversee essential document collection, tracking & review.
• Support the collection of country and site level intelligence
• Support Ethics Committee and 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 or maintain sites for a study as appropriate.

Your profile

• Bachelor’s Degree with a minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
• Experience in study start-up including ICF activities
• Flexibility to assume a workload which frequently necessitates an adjustment of priorities.
• Goal oriented, self-starter with proven ability to work independently.
• Able to proactively identify issues and provide potential solutions for resolution.
• Detail oriented.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
• Proficiency with Veeva Vault and all applications of Microsoft Office.
• Good interpersonal skills.
• Comfort with ambiguity; ability to act without having the total picture.

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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our 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, LifeWorks, offering 24-hour access to a global network of over 80,000 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 site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here