SENIOR CLINICAL RESEARCH SCIENTIST

MCR International | Executive Search; Barcelona; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

A multinational pharmaceutical company is seeking a Senior Clinical Research Scientist to oversee clinical trials and ensure compliance with regulations. The ideal candidate has at least 2 years of trial management experience or 4-5 years as a senior CRA. Responsibilities include designing and monitoring studies, liaising with health authorities, and ensuring regulatory compliance. Proficiency in English is required.

Formación

• Minimum 2 years of experience in management of clinical trials.
• Experience as a senior CRA with autonomy for 4-5 years.
• Familiar with EMA and FDA processes.

Responsabilidades

• Design, contract, and monitor clinical and pre-clinical trials.
• Request authorizations from Health Authorities for clinical studies.
• Evaluate clinical trial results and file pertinent documentation.

Conocimientos

Management of clinical trials

Clinical Research Associate (CRA)

Knowledge of bioequivalence studies

Interacting with Health Authorities

Gene therapy clinical operations

High proficiency in English

Educación

Bachelor's degree in Health Sciences

Descripción del empleo

Join to apply for the SENIOR CLINICAL RESEARCH SCIENTIST role at MCR International | Executive Search

Multinational Pharmaceutical company, with innovative drugs, is looking for a Senior Clinical Research Scientist

Your mission :

To correctly plan, design and monitor the different tasks related to the execution and oversight of clinical trials and bioequivalence studies, following current national and international regulations, as well as the company's internal SOPs, with the final purpose to obtain the final clinical reports and the corresponding dossier modules that granted the registration of a drug product.

Your major accountabilities

Responsibilities

• Design, contracting, oversight and monitoring of clinical and pre-clinical trials.
• Identify, select and hire contract research organizations, vendors and / or public sites to perform clinical studies.
• Request the pertinent authorizations to the applicable Health Authorities to perform clinical studies, as well as the corresponding certificates and all the required documentation.
• Inform and interact with the Pharmacological Development Unit to obtain the medication from the clinical trials of the company’s affiliates and their subsequent return, when applicable.
• Evaluate the consistency of the results of clinical trials. File all the generated documentation in association with a clinical trial performance.
• Update and / or prepare new SOPs (PNTs) of the Department.
• Control the evolution and follow-up of the clinical trial and alert about possible incidents.
• Act as valid interlocutor with the Clinical Trials Quality Assurance Unit and respond to audit reports.
• Preparation of Module 5 of the drug registration dossier.
• Provide technical support to the Registration Department in its relationship with the Health Authorities during the evaluation of registration files.

We would like you to have

• Minimum experience of 2 years in management, coordination and conduct of clinical trials OR 4-5 years developing tasks as a senior CRA (Clinical Research Associate) with complete autonomy.
• Phases 1 experience including Bioequivalence, PK, DDI studies
• Familiar with Competent Authorities interactions (EMA, FDA)
• Experience in the field of generic specialties and clinical bioequivalence studies is extremely valued.
• Clinical Operation Overview experience in therapeutic advanced clinical trials will also be valued.
• Knowledge of bioequivalence studies procedures and the applicable regulation in different territories
• Bachelor's degree in Health Sciences, preferably Pharmacy, Biology or Biochemistry.
• High English

Seniority level

• Associate

Employment type

• Full-time

Job function

• Science
• Industries
• Pharmaceutical Manufacturing

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