Clinical Study Monitor

## Clinical Study Monitor (PK/PD & Biomarkers Focus)
- CDI
- F/MApply: Haute Garonne (31): Full time: Posted Today: JR113592# **Who we are ?We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the \"We Care Movement,\" a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better. Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement\".# Your missionWe 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...# # **Who you are ?#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