Study Start Up Associate II

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Assist in the initiation and activation activities for sites.

• Collaborate directly with designated sites to collect and review all necessary essential documents.

• Work alongside the internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to enhance overall SSU metrics and streamline processes.

• Ensure that standards are consistently applied to SSU processes across various projects.

• Evaluate essential documents required for site start-up, including but not limited to: ICF, FDF, 1572, CVs, etc.

• Quickly identify and address potential delays in site activation and escalate issues to the relevant team members.

• Monitor all actions and communications with sites to ensure that timelines for studies and assigned sites are met.

• Assist in resolving escalated issues raised by CROs and Clinical Operations teams in collaboration with the internal Study Startup team.

• Assess and provide insights to management regarding site performance metrics.

• Confirm the accuracy and completeness of the eTMF for assigned sites during the start-up phase.

⛳️ Requirements

• Bachelor's degree or an equivalent international qualification.

• A minimum of 2 years of experience in clinical research Site Start-Up within a pharmaceutical company, CRO, or relevant industry vendor.

• Ability to articulate data to support decision-making processes.

• Knowledge of and familiarity with clinical study protocols and essential documentation.

• Strong organizational, decision-making, communication, and negotiation skills.

• Proficient in Microsoft Excel, Word, and PowerPoint.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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