Senior Clinical Research Scientist

Winid; Barcelona; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An innovative consultancy is on the lookout for a Senior Clinical Research Scientist to enhance clinical trials in the pharmaceutical sector. This role involves planning, designing, and monitoring clinical studies while ensuring compliance with regulations. You will collaborate with various stakeholders to ensure the successful execution of trials and contribute to the registration of drug products. Join a forward-thinking team that values diversity and inclusion, offering a hybrid work model in vibrant Barcelona, where your expertise will help shape the future of healthcare.

Servicios

Private Health Insurance

Professional Development Opportunities

Attractive Remuneration

Inclusive and Diverse Culture

Formación

• 2+ years in management and coordination of clinical trials or 4-5 years as a senior CRA.
• Knowledge of bioequivalence procedures and regulations.

Responsabilidades

• Design, oversight, and monitoring of clinical trials and bioequivalence studies.
• Prepare and review clinical trial documents and manage regulatory submissions.

Conocimientos

Clinical Trial Management

Bioequivalence Studies

Regulatory Compliance

Planning and Organization

Attention to Detail

Proactivity

Educación

Bachelor's in Health Sciences

Master’s in Clinical Trials or Clinical Research

Descripción del empleo

Winid is a talent acquisition consultancy that offers Executive Search, RPO, and Talent Solutions.

Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.

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 of obtaining the final clinical reports and the corresponding dossier modules that granted the registration of a drug product.

Responsibilities include:

1. Design, contracting, oversight, and monitoring of clinical and pre-clinical trials.
2. Identify, select, and hire contract research organizations, vendors, and/or public sites to perform clinical studies.
3. Request the pertinent authorizations from the applicable Health Authorities to perform clinical studies, as well as the corresponding certificates and all required documentation.
4. Coordinate with the Pharmacological Development Unit to obtain medication from clinical trials of the company’s affiliates and manage their return when applicable.
5. Evaluate the consistency of clinical trial results and document all related activities.
6. Update and/or prepare new SOPs (PNTs) for the department.
7. Monitor the evolution of clinical trials and alert about possible incidents.
8. Act as a liaison with the Clinical Trials Quality Assurance Unit and respond to audit reports.

Specific accountabilities :

1. Prepare and review documents related to clinical trials: protocols, amendments, informed consent forms, CRFs, clinical study reports, analytical and statistical reports, confidentiality agreements, financing contracts, and other relevant documentation.
2. Prepare Module 5 of the drug registration dossier.
3. Provide technical support to the Registration Department during the evaluation of registration files with Health Authorities.

Qualifications and experience :

• At least 2 years in management, coordination, and conduct of clinical trials OR 4-5 years developing tasks as a senior CRA with complete autonomy.
• Experience with Phase 1 studies including Bioequivalence, PK, DDI studies.
• Familiarity with interactions with Competent Authorities (EMA, FDA).
• Knowledge of bioequivalence procedures and regulations across different territories.
• Bachelor's degree in Health Sciences, preferably Pharmacy, Biology, or Biochemistry.
• Soft skills: Planning, organization, autonomy, attention to detail, assertiveness, proactivity, and flexibility.

Preferred qualifications :

• Experience in generic specialties and clinical bioequivalence studies is highly valued.
• Experience in clinical operations for advanced therapeutic trials is a plus.
• Master’s degree in Clinical Trials or Clinical Research is advantageous.

What we offer :

• Professional development in a leading pharmaceutical company with international growth.
• Attractive remuneration based on experience and skills.
• Private health insurance for all employees.
• Inspiring leadership and an inclusive, diverse culture.
• Hybrid role in Barcelona.