Study Start Up Associate

This is a fully remote position, open to applicants in Germany, +2 more countries.

📋 Description

• Oversee the initiation of clinical trials, ensuring adherence to regulatory standards.

• Assist with site start-up and activation processes.

• Collaborate directly with assigned sites for the collection and review of essential documents.

• Work alongside internal Study Startup, CROs, Clinical Operations teams, and TAU partners to enhance SSU metrics and workflows.

• Ensure consistent application of standards to SSU processes across various projects.

• Examine site essential documents for start-up, such as ICF, FDF, 1572, and CVs.

• Identify and address potential site activation delays while escalating issues as necessary.

• Monitor actions and communications with sites to meet study and site timelines.

• Assist in resolving escalated issues in coordination with the internal Study Startup team.

• Review and provide managerial feedback regarding site performance metrics.

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

⛳️ Requirements

• Bachelor's degree or its international equivalent.

• 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 that are data-driven.

• Familiarity with clinical study protocols and essential documentation.

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

• Proficient in Microsoft Excel, Word, and PowerPoint.

• Authorized to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary accompanied by 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.