Descripción de la oferta
In a nutshell Position: Clinical Scientist Location: Madrid, Hibrid Want to know more? mAbxience is a global biopharmaceutical company committed to innovation and excellence in the development and manufacturing of biotechnological medicines. We operate with a strong focus on quality, regulatory compliance, and scientific rigor to improve patient outcomes worldwide. What are we looking for? The Clinical Scientist is a member of the Medical Department responsible for the execution of day-to-day medical and scientific activities within assigned clinical studies. The role supports the design, execution, and documentation of clinical trials under the accountability and strategic oversight of the Global Clinical Lead (GCL). This role is assigned to clinical development programs of sufficient complexity. In simplified programs where no Clinical Scientist is assigned (e.g. PK studies in healthy volunteers), the Global Clinical Lead will directly perform these operational medical activities 1. Operational Medical Oversight (Responsible) - Conduct ongoing medical review of clinical trials and report findings, risks, and recommendations to the Global Clinical Lead. - Perform routine AE/SAE medical review and follow-up in alignment with the Safety Medical Monitoring Plan. - Conduct medical monitoring activities including protocol deviations, eligibility assessments, and medication reviews. - Perform coding review and medical review of tables and listings. - Participate in internal and CRO medical meetings and support medical discussions with investigators. - Escalate safety signals, protocol concerns, and medical risks to the GCL. 2. Study Documentation & Data Review Support (Responsible) - Draft and support the review of Medical Management Plans, Medical Data Review Plans, and SAP-related medical sections. - Support interim and final data analyses by preparing medical review summaries. - Support sponsor execution of statistical dry runs. - Coordinate operational medical activities related to DSMB/IDMC under the direction and accountability of the GCL. 3. Study Design & Development Support - Contribute to the drafting and review of clinical study protocols, amendments, and informed consent forms. - Provide scientific input to study design discussions under GCL guidance. 4. Cross-Functional Medical Support - Act as first point of contact for day-to-day medical queries from Clinical Operations, Pharmacovigilance, and Regulatory Affairs. - Support routine safety activities in collaboration with the Pharmacovigilance Department. - Contribute to responses to regulatory queries and deficiency letters. - Assist in the development of scientific publications and congress materials. 5. Departmental Contribution & Development (CLOP, PV, Medical Affairs and regulatory,scientific) - Support development and maintenance of medical SOPs. - Participate in Medical Department meetings and educational initiatives. - Engage in structured training and continuous professional development. What do you need?
