Summary
-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
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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.
