Under the direction of the Clinical Study Manager Group Head, or equivalent, the Sr. Clinical Study Manager is accountable for the day to day planning, executing and reporting, (from site feasibility up to and including study close-out), of assigned Innovative Medicines Phase I-IV Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements. The Sr. CSM may coordinate activities of other CSM associates with large studies that require multiple CSMs support.
The Sr. CSM is the single point of contact and local study team lead, within the Country/Cluster, for the assigned studies. The Sr. CSM works independently assuring aligned communication with Country/Cluster Clinical Research Associates (CRAs), CRA Managers and other key Country Trial Monitoring leadership on the execution and progress of their studies. The Sr. CSM is accountable to communicate with and support relationships with clinical investigators. The Sr. CSM collaborates with Country medical/clinical colleagues, global clinical teams and directs activities to execute and deliver their assigned studies.
Trial Monitoring strategy
In collaboration with the Trial Monitoring key stakeholders, (CSM Group Head, Regional Operations Manager (ROM), local/global medical, Trial Operations Manager (TOM), and global clinical, assists in the development of local study execution plans and timeline commitments for a country/cluster
Partners with global clinical team on study execution strategies
Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
Allocation, initiation and conduct of trials
Independently directs study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study
Independently leads study site selection in collaboration with Country/Cluster Trial Monitoring and Medical
Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues, escalating as necessary
Works with local Drug Supply Management, aligned with BPA, to forecast local IMP and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial/assigned trial sites
Ensures sites are prepared for Ready to Initiate Site (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
Is the operational subject matter expert responsible for maintaining a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel. Is a resource for global teams on local operational content of study protocols
Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
Oversees local clinical team activities to achieve study timelines and quality execution according to Novartis standards and local and international regulations
Chairs local study team meetings, participates in global clinical study team meetings, as a Country/Cluster representative of the global Clinical Trial Team and is the single point of contact for the conduct of assigned studies
Maintains oversight of Country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identify data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
Tracks that all study close out activities are performed, in a timely manner, in collaboration with CRAs and key study stakeholders
Delivery of quality data and compliance to quality standards
Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Conducts or coordinates local investigator meetings, as needed and is a key contributor to global investigator meetings for operational activities
Is mentor/coach for other CSMs, CRAs, Clinical Trial Associates and site personnel, as required
Ensures documentation of training (global/regional/local investigator meeting minutes, participants lists, certificates, etc.) is archived in the Trial Master File
Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/escalating to regions, and/or global teams, as appropriate
Is the primary escalation point for issues in monitoring visit reports (MVRs), for the assigned studies, post CRA Manager review, (may act as primary reviewer of MVRs in countries where CRA Managers do not exist). Responsible for evaluating trends identified in MVRs and communicating/escalating to Regions, and/or global teams, as appropriate
Communicates with CRAs and their managers to ensure issue resolution in a timely manner
Provides feedback about the quality of monitoring activities to CRA Managers and local QA as appropriate
Supports inspection readiness and submission preparation for monitoring related activities and assists and coordinates with country/cluster Trial Monitoring and Quality Assurance for internal audits and HA inspections, as required, and ensures implementation of corrective actions within specified timelines
Participates in multiple disciplinary taskforces to support continuous improvement initiatives
Budget and productivity
Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study start up, under the direction of their manager
Tracks study budget with appropriate study budget responsible in Country/Cluster. Ensures timely TCF preparation and submission in collaboration with the TCF specialist in the Country/Cluster
Processes invoiceable items and/or coordinates this activity with other CSMs for site level clinical study activities to allow timely payments
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management is preferable
Minimum 7 years experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials.
Capable of leading in a matrix environment, without direct reports, but can coordinate the activities of others
Subject matter expertise in understanding all aspects of clinical drug development with particular emphasis on monitoring and study execution
Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues.
Excellence in 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
Demonstrated strong negotiation and conflict resolution skills both internal and external (site relationships).
Developed influencing skills
Communicates effectively with senior leaders in a local/global matrixed environment
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