Assoc Research Scientist, Bioanalytical Study Manager

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

📋 Description

• Oversee and monitor ongoing clinical studies to ensure that timelines, data flow, and deliverables remain on schedule.

• Serve as a primary contact for CROs and external laboratories, engaging in regular status meetings and following up on action items.

• Evaluate study documents, reports, and vendor outputs to identify issues, risks, and opportunities for enhancing clinical study monitoring.

• Review trial-related documentation connected to the GxP vendor (e.g., CTP, SAP, TLFs, CSR, Lab manual).

• Ensure that the bioanalytical vendor receives copies of trial-related documents and pertinent amendments (such as clinical trial protocols).

• Assess and approve study plans for the bioanalytical phases of clinical trials.

• Review and approve bioanalytical reports when applicable.

• Document planned and unplanned changes to the study plan and vendor procedures in accordance with vendor guidelines (e.g., in amendments and deviations), ensuring they are communicated to the sponsor as outlined in the quality agreement or communication plan.

• Organize and manage study documentation using Microsoft Teams, SharePoint, and internal dashboards, ensuring information is accessible and current.

• Keep the Clinical Trial Team adequately informed about project status, ensuring relevant information (such as end-of-study timelines and data delivery requirements) is communicated to the project manager and bioanalytical vendor.

• Elevate issues related to timelines, budget, or communication to the appropriate stakeholders.

⛳️ Requirements

• PhD in Immunology, Molecular Biology, or a closely related life sciences field, or a Master's degree with a minimum of 4 years of relevant industry experience.

• Proven experience in clinical study monitoring/management within a pharmaceutical, biotechnology, or CRO setting.

• Significant experience collaborating with external partners, CROs, and laboratories.

• Familiarity with bioanalytical techniques, specifically biologics- and antibody-based assays.

• Experience supporting the analysis of human samples in clinical trial environments.

• Thorough understanding of GCP, GCLP, and other applicable global regulations.

• Exceptional organizational skills, capable of managing multiple projects and maintaining structured, accurate documentation.

• Proactive approach to work, with the ability to anticipate stakeholder needs and prepare relevant materials ahead of time.

• Strong communication and collaboration abilities, capable of working effectively across cross-functional and international teams.

• Willingness to travel to Ghent, Belgium, on a monthly basis.

🏝️ Benefits

• Full-time benefits.

• Monthly travel to Ghent, Belgium is required.