Summary: This role contributes to global clinical trials, ensuring timely and quality delivery of outcomes, and focuses on operational execution of various clinical research tasks while supporting budget management. Highlights: 1. Contributes to all aspects of global clinical trials for quality outcomes. 2. Responsible for executing assigned clinical research tasks. 3. Supports the management and tracking of trial budgets. ### **Summary** Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial process. Contributes to operational excellence through process improvement and knowledge sharing. * Responsible and accountable for execution of assigned clinical research tasks related to, Investigator Initiated Trials (IITs), Expanded Access Programs (EAPs, MAPs), Research Collaborations (RCs), and non\-Interventional studies (NIs) ### **About the Role** **Key responsibilities:** * Operational clinical activities like process improvement or other line function initiatives. * Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt \-Distribution of marketing samples (where applicable) * Preparation of trial related documentation, TMF maintenance, ensuring key processes and documents are maintained/updated on time (e.g. TPSR, ICF Clinical Review, TMF). * Supports the management and tracking of trial budgets including payments working closely with the appropriate partners **Main Requirements:** * Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution. * \+6 years' experience with significant clinical research or research monitoring experience (comparable to 6 years) that provides the required knowledge, skills and abilities and experience mentoring or training others. * Evaluate medical research data and proficient knowledge of medical terminology. * Effective oral and written communication skills, with the ability to communicate effectively with medical personnel. * Strong customer focus. * Fluent in English. **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:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits\-rewards Division US Business Unit Marketing Location Mexico Site INSURGENTES Company / Legal Entity MX06 (FCRS \= MX006\) Novartis Farmacéutica S.A. de C.V. Functional Area Research \& Development Job Type Full time Employment Type Regular Shift Work No VIDEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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 \[email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.