Overview
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
We are seeking a pioneering Senior Clinical Research Associate who is passionate about driving change and leading teams toward success in clinical trials. This role requires a dynamic individual who thrives in a fast-paced environment and is committed to making a meaningful impact in the field of clinical research.
Preferred candidate location is Madrid, Catalonia or Andalucia.
Your role
As a Senior Clinical Research Associate you will:
* Be assigned to multiple protocols, sites and therapeutic areas.
* Assist in the identification and evaluation of potential investigative sites.
* Participate in and/or conduct pre-study qualification visits.
* Prepare and conduct site initiation visits (SIVs), train site staff on the protocol, eCRF, safety reporting, and study procedures.
* Plan, conduct, and document routine monitoring visits (on-site and remote) and close-out visits according to the monitoring plan.
* Perform source data verification (SDV) to ensure accuracy, completeness, and reliability of data entered in the eCRF.
* Ensure Data Monitoring oversight. Verify the integrity of data and adherence to study protocols and compliance with SOPs, GCP, and applicable regulatory requirements.
* Ensure proper reporting and documentation of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
* Track site performance (recruitment, data entry, query resolution) and implement corrective actions as needed.
* Identify and resolve issues related to study conduct, including data discrepancies and protocol deviations.
* Review essential documents in the Investigator Site File (ISF) and Trial Master File (TMF) for completeness and currency.
* Ensure site inspection readiness. Support sites during audits and regulatory inspections, including preparation and follow-up of findings.
* Maintain effective communication with investigators, site staff, and internal teams to facilitate smooth trial operations, including creation and distribution of communication materials.
* Support preparation and submission of regulatory documents as required by local and international regulatory authorities.
* Participate in project meetings and contribute to the development of clinical trial material, plans and strategies.
Who you are
Degree in Life Sciences (e.g., Pharmacy, Medicine, Biology, Nursing) or related field required.
Advanced degree (MSc, PharmD, MD) is an advantage
Clinical Research Associate/ Clinical Research certification preferred.
Competencies
* Problem-solving and issue-resolution mindset.
* Ability to work both independently and as part of cross-functional teams.
* Strong interpersonal skills and ability to build trust with site staff.
* Ethical mindset and strong commitment to patient safety and data integrity.
Skills:
* Solid understanding of ICH-GCP, EMA/FDA and local regulatory requirements.
* Strong organizational and time-management skills, with ability to manage multiple sites/studies in parallel.
* High attention to detail and quality mindset.
* Excellent verbal and written communication skills in Local language and fluency in English (oral and written)
* Proficiency in MS Office and clinical trial systems (CTMS, EDC, eTMF).
* Strong knowledge of clinical development (principles and concepts as well as regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines, and applicable regional/local regulations)
* Strong experience (6+ years) in clinical research and site monitoring from start to end, preferably as a CRA in pharmaceutical, biotech, or CRO
* Experience in clinical operations – ideally across Phases (I-IV) Oncology and/or Neurology and/or Immunology therapeutic area experience desired
* Ability and willingness to travel frequently (depending on study needs).
What we offer
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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