Study Start Up Associate II

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

📋 Description

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

• Participate in site start-up and activation tasks, taking ownership of deliverables and collaborating effectively.

• Collaborate directly with designated sites for the collection and evaluation of essential documents.

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

• Ensure the application of standards to SSU processes across all projects.

• Assess site essential documents for start-up, including ICF, FDF, 1572, and CVs.

• Identify and address potential site activation delays, escalating issues to the relevant team members.

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

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

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

• Ensure the eTMF's accuracy and completeness for assigned sites during the start-up phase.

⛳️ Requirements

• Bachelor’s degree or an equivalent qualification from an international institution.

• 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 data-driven decision-making processes.

• Comprehensive knowledge of clinical study protocols and essential documents.

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

• Proficient in Microsoft Excel, Word, and PowerPoint.

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

🏝️ Benefits

• Competitive base salary.

• Performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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