Study Site Management Specialist

ICON San Antonio; North Carolina; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Global Employee Assistance Programme (

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Site Activation Lead in the United States (North Carolina) to support sponsor-dedicated model operations and global expertise. You will act as the primary site contact for end-to-end study activity, coordinating cross-functional teams and ensuring timely study activation.

Responsibilities include documenting processes, tracking activities, and supporting regulatory submissions.

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.
• Goal oriented, self-starter with ability to work independently.
• Proactively identify issues and provide solutions.
• Detail oriented.
• Ability to manage multiple tasks and meet timelines.
• Proficiency with Veeva Vault and MS Office applications.
• Good interpersonal skills.
• Comfort with ambiguity; able to act without the total picture.

Responsibilities

• Participate in development of in-house model process documents.
• Serve as primary site contact for end-to-end study activity for assigned sites and countries.
• Provide updates to cross-functional teams on study and site activity.
• Use systems to track activities and produce reports and metrics.
• Oversee essential document collection, tracking & review.
• Support collection of country and site level intelligence.
• Support Ethics Committee and Regulatory Authority submissions.
• Complete or support country/site-specific activation activities as needed.

Skills

Veeva Vault proficiency

Microsoft Office

Cross-functional collaboration

Independent work

Detail oriented

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva Vault

Microsoft Office Suite

Job description

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