Study Site Management Specialist

This is a fully remote position, open to applicants in North Carolina, +1 more state.

📋 Description

• Contribute to the creation of internal model process documentation.

• Act as the primary point of contact for comprehensive study activities at designated sites and countries.

• Attend assigned Study Site Management team meetings and deliver detailed updates on study and site activities to cross-functional teams.

• Employ systems and tools to monitor assigned tasks and generate necessary reports and metrics.

• Manage the collection, tracking, and review of essential documents.

• Assist in gathering intelligence at both country and site levels.

• Facilitate submissions to Ethics Committees and Regulatory Authorities.

• Complete, oversee, and/or assist with activities at the country and site level required for the initiation or maintenance of study sites, such as import/export licenses, radiation board approvals, and biobank committee consents.

⛳️ Requirements

• Bachelor’s Degree with at least five years of relevant experience in the biopharmaceutical or CRO industry.

• Experience in study start-up, including ICF activities.

• Ability to adapt to a workload that often requires priority adjustments.

• Goal-oriented, self-motivated individual with a demonstrated capacity to work independently.

• Capable of proactively identifying issues and suggesting potential solutions for resolution.

• Detail-oriented.

• Proficient in managing multiple tasks simultaneously while meeting deadlines as per specified timelines.

• Familiarity with Veeva Vault and all Microsoft Office applications.

• Strong interpersonal skills.

• Comfortable with ambiguity and able to act without having the complete picture.

• Legal authorization to work in the country where this position is located.

🏝️ Benefits

• Competitive base salary along with performance-based incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.