Serves as the primary site manager for assigned clinical investigative sites
Liaison between Novartis and sites to ensure collaboration and deliver on milestones
Manages assigned study sites/networks and conducts phase I-IV protocols
Facilitates preparation and collection of site and country level documents
Performs Site Initiation Visit, ensures site personnel are adequately trained
Conducts continuous monitoring activities (onsite and/or remote)
Implements site management activities to ensure compliance with protocols, GCP, global and local regulations
Accountable for continuously updating all relevant electronic systems
Ensures timely delivery of high-quality data supporting Trial Monitoring goals
Collaborates with internal stakeholders to manage data query resolution process

BS/BA degree in Scientific, Healthcare or related field
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Ability to manage multiple priorities and time efficiently
Excellent Site management capabilities with demonstrated negotiating and problem-solving skills
Strong communicator and presentation skills (oral and written)
Fluent in both written and spoken English
Minimum of 3 years of experience in site monitoring strongly preferred
RLT, CAR T or Oncology experience a plus!

Health insurance
Life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves

Senior Clinical Research Associate

Key skills