Study Start Up Associate II

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

📋 Description

• Lead the commencement of clinical trials, ensuring adherence to regulatory standards.

• Participate in site initiation and activation tasks, taking ownership of your responsibilities and collaborating effectively.

• Engage directly with assigned sites for the collection and review of all essential documents related to site activities.

• Collaborate with 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.

• Review essential documents for site initiation, including but not limited to: ICF, FDF, 1572, CVs, etc.

• Quickly identify and address potential site activation delays, escalating issues to the relevant team members when necessary.

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

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

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

• Ensure the accuracy and completeness of the eTMF for assigned sites during the startup phase.

⛳️ Requirements

• Bachelor's degree or an equivalent international qualification.

• A minimum of 2 years of experience in clinical research.

• Experience in Site Start Up within a pharmaceutical company, CRO, or relevant industry vendor.

• Ability to articulate data to aid in decision-making processes that are data-driven.

• Familiarity with clinical study protocols and essential documents.

• 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.

• Learning and development opportunities through structured training and career pathways.