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Job Description Summary
WORK ARRANGEMENT: Hybrid Working, #LI-Hybrid
Job Description
As a CRMA, you will provide Clinical Development and indication expertise specific to Country/Cluster, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines.
Key Responsibilities
Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language.
Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
Drives patient recruitment strategies and proactively address enrolment and data quality challenges.
Collaborate across functions to deliver high-quality clinical trials on schedule and in compliance.
Essential Requirements
Advanced scientific degree in Medicine, Pharmacy, or Life Sciences and ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice
Ability to manage a study from a scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
Ability to lead effectively by communicating well, motivating a cross functional team, and handling and delegating responsibilities.
Ability to evaluate protocol feasibility and solve complex clinical challenges.
Sound understanding of the overall clinical development process, and International Conference on Harmonization (ICH)/ Good Clinical Practice (GCP) principles
Excellent communication skills with experience influencing cross-functional stakeholders. Fluency in Spanish & English are essential.
Demonstrate an agile mindset by setting clear priorities, collaborating openly, and using feedback to make step-by-step improvements
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
Accessibility and accommodation:
Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to tas.mexico@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards:
Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Skills Desired
Clinical Research, Clinical Trials, Drug Development, Health Sciences, Regulatory Compliance