Clinical Study Monitor

We are seeking a Clinical Study Monitor (PKPD & Biomarkers Focus) to support Clinical Pharmacology and Biomarker Experts in the design, execution, and analysis of clinical studies within the R&D team at Pierre Fabre Medical Care in Toulouse (Langlade site, Oncopole).
This role ensures high-quality operational oversight of PK, PD, and biomarker components within early and late phase clinical trials, while contributing to regulatory documentation, study governance, sample management, and data integrity.Your role within a pioneering company in full expansion:

Key Responsibilities
1. Study Design & Operational Support* Participate in the design, planning, and implementation of clinical studies in close collaboration with Clinical Pharmacology, Biomarker, and Clinical Operations teams.
* Provide operational and scientific support for PK/PD and biomarker strategies throughout the study lifecycle.
* Coordinate with internal and external stakeholders to ensure appropriate bioanalytical and biomarker resources are in place.2. Sample & Bioanalysis Oversight* Oversee the Clinical CRO in charge of the end-to-end sample management oversight process (collection, handling, logistics, storage, and shipment).
* Ensure timely and compliant execution of bioanalysis activities, both internal or outsourced.
* Monitor the quality, timelines, and adherence to study plans for all PK/PD and biomarker analyses.3. Documentation & Regulatory Support* Ensure documentation accuracy, completeness, and proper maintenance in RIM and related electronic systems.
* Maintain oversight of study‐related documentation, version control, and compliance with internal processes and regulatory expectations.4. Data Management & Analysis Coordination* Support the management, cleaning, and validation of PK, PD, and biomarker datasets.
* Coordinate with data management, statisticians, and clinical pharmacologists to ensure robust and timely analyses.
* Ensure the drafting, review, or monitoring of PK/PD reports and PK/PD sections of clinical study reports (CSR).
* Oversee outsourced analyses or reporting activities performed by CROs or external partners.5. Study Budget, Planning & Vendor Oversight* Ensure accurate budget tracking and forecasting for PK/PD and bioanalytical activities within clinical studies.
* Manage operational timelines and task planning for internal and external PK/PD and biomarker deliverables.
* Support vendor selection, contracting, and performance oversight (CROs, central labs, bioanalytical labs).
This position is compatible with teleworking up to 2 days a week according to company rules.

We offer
an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation...# Qui êtes-vous ?Your skills at the service of innovative projects:Education* Master’s degree or equivalent in Life Sciences, Pharmacy, Biology, Biomedical Sciences, or related field. A PhD is a plus but not required.Experience* Experience in clinical study conduct, clinical operations, clinical pharmacology, or biomarker operations.
* Good understanding of GCP, sample management workflows, and bioanalytical processes.
* Experience with regulatory documentation and clinical trial governance is an advantage.
* Prior interaction with CROs and external laboratories strongly preferred.Technical & Professional Skills* Basic understanding of PK/PD principles and biomarker assays.
* Specialized training in NCA pharmacokinetic data analysis would be preferable. Proficiency of pharmacokinetic data analysis software (WNL) is a plus.
* Familiarity with clinical databases (EDC, LIMS) and document management systems (RIM or equivalent).
* Strong organizational skills with the ability to coordinate complex study activities.
* Excellent written and verbal communication skills in English; French is a plus.Behavioral Competencies* Strong cross‐functional collaboration and stakeholder management.
* Proactive problem‐solving and attention to quality.
* Ability to drive timelines, anticipate risks, and maintain study oversight.
* Team‐oriented mindset and willingness to support scientific colleagues. #J-18808-Ljbffr