Your Key Responsibilities:

Trial Monitoring strategy:

• Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis)

Allocation, initiation and conduct of trials:
• Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
• Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
• Facilitates the preparation and collection of site and country level documents
• Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required.

• Conducts continuous monitoring activities (onsite and/or remote). Implement site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.

• Accountable for continuously updating all relevant electronic systems to perform job functions

• Takes on the responsibility as SME (Subject Matter Expert) as needed

Delivery of quality data and compliance to quality standards:

• Monitors studies as per current legislations, ICH/GCP and Novartis standards
• Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.

•  Identifies, resolves & escalates issues appropriately
• Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry

• Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities

•Partners with SSU CRA to ensure seamless transition of site responsibility

Role Requirements:

BS/BA degree. Scientific or healthcare discipline preferred
• Minimum of 3 years’ experience in site monitoring strongly preferred for Senior level

• Previous CRA experience required for Senior level

• 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 (oral and written)

• Fluent in both written and spoken English

This is a dual level posting. The final level and title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.

The salary for this position is expected to range between $103,600 and $192,400 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver’s license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. 

COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.