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This is a REMOTE based role. Candidates can be located anywhere in the US
The Clinical Research Associate (CRA) Manager is responsible for the hiring, training, development and assignment of CRAs to ensure qualified Monitoring resource assignment to the Global Drug Development (GDD) portfolio. The CRA Manager is responsible for CRA (Trial Monitoring and external) quality and compliance of clinical monitoring activities related to investigator site qualification, initiation, and trial conduct (recruitment, quality data collection). The CRA Manager is responsible for CRA performance to KQI’s, ensuring implementation and appropriate application of established Monitoring procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations.
Major Accountabilities (Describe the 5-7 main results of the role to be achieved)
Trial Monitoring strategy
• Collaborates with Trial Monitoring Country Head, Cluster Head or Development Unit Head to implement country innovative practices and patient engagement tactics (as appropriate) to advance clinical trial planning, execution and quality in line with Country CSO and Medical Director strategies
• Develops investigational site territory by identifying and qualifying new sites for participation in GDD portfolio in collaboration with Country/Cluster/Development Unit Head and, Country CSO/Medical Director
Allocation, initiation and conduct of trials
• Is strategically and operationally involved in allocating new trials in collaboration with Country/Cluster/Development Unit Head and local CSO/Medical Director teams during trial feasibility/allocation
• Ensures country trial site selection, activation, enrolment, data flow and timeline commitments are delivered per established Trial Monitoring KPI’s trial objectives
• In collaboration with CSMs, reviews the status of planned versus actual patient recruitment and supports implementation of strategies to correct deviations from proposed plan enrolment according to monitoring procedures
• Liaises with local and global TA/BU clinical teams (e.g. escalates unresolved site issues) to enhance Novartis relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoring
Delivery of quality data and compliance to quality standards
• Is accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation/resolution
• Ensures CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with local training and Trial Monitoring Excellence group
• Is responsible for execution of annual Field Monitor Accompanied Visit Plan to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies in collaboration with local or Trial Monitoring Excellence
• Collaborates with Clinical Study Manager (CSM) Manager for monitoring trends that require targeted training and/or development of CRAs to deliver to trial KPI and KQI goals
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Supports CPO / site audits and inspection and ensures CAPA follow-up and implementation for monitor and site identified issues
• Manages CRA adherence/compliance to SOPs and required training curricula
Management of people and resources management
• Is responsible for the hiring, training, development and retention of a team of CRAs to deliver quality monitoring to the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
• Performs ongoing assessment and allocation of monitoring resources within Country, Cluster or Development Unit to ensure balanced CRA workload for quality monitoring
• Ensures CRAs have the required level of Monitoring and Development Unit (disease) area knowledge and skills to successfully deliver to protocol requirements
• Is responsible for managing and addressing CRA performance targets per defined Trial Monitoring key trial and quality performance indicators, including managing site recruitment commitments, timely data entry and issue resolution
Budget and productivity
• Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy, and to ensure within local targets for monitoring visits budget (as appropriate)
The pay range for this position at commencement of employment is expected to be between $144,00.00 and $216,000.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
Diversity & Inclusion / EEO
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.
What you'll bring to the role:
Education: A degree in scientific or health discipline required and advanced degree preferable
Languages: Fluent in both written and spoken English, local language as needed in clusters/countries.
• Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials
• Experience in project management and, evidence of team leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
Skills & Knowledge:
• Demonstrated negotiation and conflict resolution skills
• Communicate effectively with site personnel, country and global associates
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. 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 [email protected]
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network