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About the client:

We are seeking a Senior Clinical Research Scientist to join one of our clients in the pharmaceutical sector. The position is based in Barcelona and offers a hybrid work model.

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.

Mayor accountabilities:

• 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.
• To 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.

Specific accountabilities:

• Preparation and review of documents related to clinical trials: synopsis, clinical study protocols and amendments, informed consent forms, CRFs, clinical study reports, analytical and statistical reports, confidentiality agreements, financing contracts and other relevant documents that apply.
• 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 

• 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).
  
• Knowledge of bioequivalence studies procedures and the applicable regulation in different territories.
• Bachelor's degree in Health Sciences, preferably Pharmacy, Biology or Biochemistry.
• Fluent in english & spanish. 
• Required soft skills: Planning, organization, autonomy, attention to detail, assertiveness, proactivity, and flexibility.

Ideal experience:

• 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. 
• Master’s degree in Clinical Trials, Clinical Research is a plus.

What we offer:

• Individual Professional development in a leading pharmaceutical company with an ambitious international growth strategy.
• Attractive remuneration according to the experience and skills provided.
• Flexible working hours
• Private health insurance for all employees
• An inspiring leadership team that drives performance.
• An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert & excellent team!
• Hybrid role