Study Start Up Associate II

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

📋 Description

• Spearhead the commencement of clinical trials and play a key role in the progression of innovative treatments and therapies.

• Engage in site initiation and activation tasks, assuming responsibility for deliverables while collaborating effectively.

• Collaborate closely with designated sites to gather and review essential documents.

• Work in partnership with 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 various projects.

• Examine site essential start-up documents, 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 issues escalated by CROs and Clinical Operations teams in collaboration with the internal Study Startup team.

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

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

⛳️ Requirements

• BS degree or an equivalent international qualification.

• Minimum of 2 years of experience in clinical research site start-up within a pharmaceutical company, CRO, or a relevant industry vendor.

• Capability to articulate data to support data-driven decision-making processes.

• Familiarity with clinical study protocols and essential documents.

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

• Proficient in Microsoft Excel, Word, and PowerPoint applications.

• Legal authorization to work in Italy, the location of the role.

🏝️ 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.

• Reasonable accommodations available throughout the recruitment process.