Assoc Research Scientist (Bioanalytical Study Manager) client dedicated, FTC

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Job Description

Assoc Research Scientist (Bioanalytical Study Manager) - client dedicated FTC

This is a 1 year fixed term contract for maternity cover. This role is home based (fully remote) with monthly travel to Ghent Belgium required.

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies

Within our Analytical Services team we have a functional service provider solution which is an outstanding partnership that allows our customers to use the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.

We are seeking an Associate Research Scientist to support bioanalytical oversight for clinical this role you will act as a sponsor representative/study monitor for one or more studies and supports the bioanalytical study phases of clinical trials working closely with CROs external laboratories and internal stakeholders to help ensure study timelines documentation data flow and deliverables are executed to a high standard.

This is an excellent opportunity for someone with clinical study monitoring/management experience and a strong foundation in bioanalysis to contribute in a highly collaborative cross-functional environment.

Key Responsibilities:

• Monitor and oversee ongoing clinical studies ensuring timelines data flow and deliverables are on track.
• Act as a key contact for CROs and external labs participating in regular status calls and following up on agreed actions.
• Review study documents reports and vendor outputs helping to identify issues risks and opportunities to optimize clinical study monitoring.
• Reviews trial related documentation with a link to the GxP vendor (i.e. CTP SAP TLFs CSR Lab manual)
• Ensures the bioanalytical vendor receives copies of trial related documentation and relevant amendments (e.g. clinical trial protocol)
• Reviews and approves study plans of bioanalytical phases of clinical trials
• Reviews and approves (if applicable) bioanalytical reports
• Oversees planned and unplanned changes to study plan and vendor procedures are documented according to vendor procedures (e.g. in amendments and deviations) and are shared with the sponsor as stipulated in the quality agreement or communication plan
• Manage and organize study documentation in Microsoft Teams SharePoint and internal dashboards ensuring information is easy to find and up to date.
• Ensures that the Clinical Trial Team is adequately informed of the project status and that relevant information (e.g. end-of-study timelines and data delivery requirements) from the Clinical Trial Team is conveyed to the project manager and bioanalytical vendor
• Escalates issues related to timelines budget or communication to the appropriate stakeholders

Requirements:

• PhD in Immunology Molecular Biology or a related life sciences discipline or a Masters degree with at least 4 years of relevant industry experience.
• Experience in clinical study monitoring/management within a pharma biotech or CRO environment.
• Strong experience collaborating with external partners CROs and laboratories.
• Knowledge of bioanalytical techniques particularly biologics- and antibody-based assays.
• Experience supporting analysis of human samples in clinical trial settings.
• Strong understanding of GCP GCLP and other applicable global regulations.
• Excellent organizational skills with the ability to manage multiple projects and maintain structured accurate documentation.
• Proactive working style with the ability to anticipate stakeholder needs and prepare relevant materials in advance.
• Strong communication and collaboration skills with the ability to work effectively across cross-functional and international teams.
• Ability to travel to Ghent Belgium on a monthly basis

Preferred Qualifications:

• Background in bioanalysis assay development assay qualification or related laboratory work.
• Experience with techniques such as ligand binding assays and LC-MS.
• Experience monitoring assay performance at external vendors and interpreting related data.
• Prior experience in a study monitor or clinical project support role in biotech or pharma.
• Demonstrated ability to manage large volumes of data and documentation with strong attention to detail.

Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.