Study Site Management Specialist

ICON plc • Blue Bell, PA

3d

About The Position

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.

Requirements

• 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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• 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.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level