Study Start Up Associate

This is a fully remote position, open to applicants in Germany, +1 more country.

📋 Description

• Oversee the initiation of clinical trials, ensuring adherence to regulatory standards, while contributing to the development of cutting-edge treatments and therapies.

• Play a key role in site start-up and activation activities, taking ownership of deliverables and collaborating effectively.

• Engage directly with assigned sites to collect and review all essential documents related to the site.

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

• Ensure consistent application of standards across SSU processes for all projects.

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

• Swiftly identify and rectify potential site activation delays, escalating issues to the relevant team members.

• Maintain a record of all actions and communications with sites to ensure timelines are met for studies and assigned sites.

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

• Analyze and provide feedback to management regarding site performance metrics.

• Ensure the eTMF for assigned sites is accurate and complete during the start-up phase.

⛳️ Requirements

• Bachelor's degree or equivalent international qualification.

• At least 2 years of experience in clinical research Site Start Up within a pharmaceutical company, CRO, or related industry vendor.

• Capability to interpret data to support decision-making processes driven by data.

• Proficient understanding of clinical study protocols and essential documents.

• Excellent 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 assurance and disability coverage.

• Employee assistance programs and wellness resources.

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