Expert Clinical Research Associate

Your Key Responsibilities:
Trial Monitoring strategy
• Assumes ambassadorial role to facilitate communication between sites and Novartis CPO to increase value to investigators
Allocation, initiation and conduct of trials
• Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables
• Takes on the responsibility as SME (Subject Matter Expert) as needed
• Manages assigned study sites and networks, if applicable, 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, ensure site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as needed
• Conducts continuous monitoring activities (onsite, remote, and RBM). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
• Is accountable for compliance in updating all electronic systems (global and local) relevant to perform job functions (e.g.: eTMF; IMPACT; Expense Report; Site Cockpit; Timecard)

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

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. (ADIS, DBL)

• Identifies issues at sites; resolves issues and escalates as appropriate

• Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry

Role Requirements

· BS/BA degree. Scientific or healthcare discipline preferred
· 7+ years of experience in all aspects of monitoring and site management
· Ability to travel up to 80% domestically (and possibly internationally) as needed to study sites and for training and meetings
· Proven proficiency of the drug development process specifically clinical trial/research
· Demonstrated ability to influence and lead others
· Advanced understanding of project management methodology as well as understanding of the structures and roles and responsibilities of personnel working in the GDD organization.
· Excellent site management capabilities with demonstrated negotiating and problem-solving skills
· Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
· Strong communicator and presenter (oral and written)

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

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,400- $195,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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