Job Description 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 general 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)
Job Description
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.
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model

📌 Clinical Sciences Manager (Xico)
🏢 Novartis
📍 Xico