Novartis Pharmaceuticals Corporation is looking for a Senior Clinical Research Associate to join our team. In this remote position, you will perform monitoring activities for Phase I-IV Pharma clinical trials, ensuring timely, high-quality data delivery and adherence to regulatory standards. The role requires up to 80% travel, with candidates ideally located near an airport in the Northeast.
What You'll Do
- Serve as the primary site manager and first point of contact for assigned clinical investigative sites.
- Manage assigned study sites and networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures.
- Facilitate the preparation and collection of site and country level documents.
- Perform Site Initiation Visits and ensure site personnel are fully trained on all trial-related aspects.
- Conduct continuous monitoring activities (onsite and/or remote) to ensure protocol, GCP, and regulatory compliance.
- Continuously update all relevant electronic systems to perform job functions.
- Take on responsibility as a Subject Matter Expert as needed.
- Ensure timely delivery of high quality, robust and reliable data from monitored sites.
- Identify, resolve and escalate issues appropriately.
- Collaborate with internal stakeholders and site personnel to manage data query resolution.
- Proactively collaborate with the Clinical Project Manager (CPM), CRA Manager, Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner.
- Partner with SSU CRA to ensure seamless transition of site responsibility.
What We're Looking For
- BS/BA degree.
- 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 manage time efficiently.
- Excellent site management capabilities with demonstrated negotiating and problem-solving skills.
- Strong communicator and presentation skills, both oral and written.
- Fluent in both written and spoken English.
- A fully valid and unrestricted driver’s license (driving is an Essential Function of this role).
Nice to Have
- Scientific or healthcare discipline preferred.
- Minimum of 3 years’ experience in site monitoring strongly preferred.
- Oncology or Neuroscience monitoring experience highly desirable.
- CAR T and/or RLT experience a plus.
Technical Stack
- Clinical Trial Management Systems (CTMS)
Team & Environment
You will collaborate with a cross-functional team including the Clinical Project Manager (CPM), CRA Manager, Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor, Strategic Site Partner, and SSU CRA.
Benefits & Compensation
- Compensation range: $103,600 - $192,400 per year.
- Performance-based cash incentive.
- Eligibility for annual equity awards (depending on level of role).
- Comprehensive benefits package including health, life and disability benefits.
- 401(k) with company contribution and match.
- Generous time off package including vacation, personal days, holidays and other leaves.
Work Mode
This is a remote position based in the U.S., with some restrictions based on legal entity. Candidates must be located near an airport, with the Northeast being a highly desirable location.
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
