Clinical Study Monitor (PK/PD & Biomarkers Focus)- CDI- F/M

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 Ph

D 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.

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