Study Start-up Associate II

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

📋 Description

• Assist in the initiation and activation processes of sites, taking ownership of your responsibilities and collaborating effectively.

• Engage directly with designated sites for the collection and assessment of all essential documents related to the site.

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

• Ensure the application of standards to the SSU procedures across various projects.

• Examine essential documents for site startup, including but not limited to: Informed Consent Forms (ICF), Financial Disclosure Forms (FDF), Form 1572, and CVs.

• Quickly identify and address potential delays in site activation, escalating issues to the appropriate team members as necessary.

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

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

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

• Ensure the accuracy and completeness of the electronic Trial Master File (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 Site Start Up within a pharmaceutical company, CRO, or relevant industry vendor.

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

• Knowledge and comprehension of clinical study protocols and essential documentation.

• Strong organizational capabilities, decision-making, communication, and negotiation skills.

• Proficiency 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.

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