The Senior CSM is accountable for independently planning, executing and reporting on a number of phase II-III and global phase IV clinical studies for the US, from planning and site feasibility through study close-out, in compliance with Novartis processes and regulatory requirements.
This position is key to good communication and professional relationships with clinical investigators and international colleagues in HQs and CPOs. This position is the single point of contact for Global Clinical Operations and Global Clinical Development.
Provide input to protocol, and operational aspects of the trial. Maintain a strong knowledge of the protocol to be able to answer questions from monitors, sites, and local internal personnel.
Independently leads trial feasibility process and CPO patient commitments: ensures two-way feedback on feasibility between global team and US.
Independently develops strategic local trial execution plan (e.g. recruitment retention, contingency plans) and timeline commitments (TAMS) for the US.
Coordinates and manages the site selection process in collaboration with the necessary line units.
Drive the conduct and completion of study start-up activities and any amendments, including the preparation of IRB/EC submission package. Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents. Ensure sites are prepared for FPFV by monitoring the status of or initiating clinical trial supply delivery, provide training as needed for monitors and site personnel, and any other activities that support site readiness to recruit. Ensure documentation of training is archived appropriately. Conduct local investigator meetings as needed and/or participate in global investigator meetings as needed.
Responsible for the initial and subsequent drug release in collaboration with the local Qualified Person
Responsible for tracking the enrolment status of all sites for the trial in the US and setting up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
Drive the conduct of the trial, track and oversee progress and status. Ensure all operational aspects are on schedule. Oversee local clinical team activities to achieve trial timelines and quality execution according to Novartis standards and local and international regulations.
Consistently reviews monitoring visit reports to identify trends/issues. Appropriately escalates issues in a timely manner and ensures resolution. Communicates with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.
Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.
Works with Program Finance Manager to track trial budget.
Accountable for coordinating data management activities through the local trial team. Communicates with monitors and Investigator sites to ensure timely resolution of data issues. Review country level data including lab values, time to date entry at sites, screen failure reasons, discontinuations rates, patient profiles, and proactively identify data entry issues to mitigate queries.
Responsible to keep reporting systems up to date (e.g. Impact/ClinAdmin, TMF, CREDI) throughout the lifecycle of the trial.
Ensure that all trial close out activities are performed, in close cooperation with field monitors and clinical trial head.
Oversee local vendor selection and performance. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
Facilitate internal audits and HA inspections as required. Assist in Monitoring implementation of corrective actions following audits and inspections in relationship with Development Quality Responsible
Mentor/coach other Local Study Mangers and CTCs
May be involved with special projects and work streams.
Expected to manage more complex trials as defined by the US organization.
Key Performance Indicators:
Timely and quality execution of trial related activities (e.g. key milestones, 100% of target enrolment at last patient first treatment, 100% clean data)
Timely submission and delivery of high quality clinical trial documentation
Data cleaning process is successfully accomplished within the required timelines in the country/group of countries
Acceptability of clinical documentation by IRB/EC and Health Authorities
Trials are executed on time, budget and in compliance with international and local regulations and Novartis internal standards
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.
Degree in scientific or healthcare discipline. Master degree preferred
Fluent in local language(s) English written and spoken
Ideally 5+ years strong experience in clinical research management
Experience in a monitor role or a role overseeing clinical trials desirable
Strong Interpersonal skills
Strong Project Management and Leadership skills
Working experience in a global team, team player
Ability to work under pressure
Ability work in a matrix environment
Displays innovative ideas and solutions
Highly proficient in negotiation skills
Highly effective in influencing others
Thought leader in job role
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