The Training Manager assists in developing, coordinating, and implementing scientific and technical training programs for new and experienced Field Monitors in support of the US Clinical Operations Oncology training strategy. The Training Manager works with the US Clinical Operations Oncology management team to provide career development, assessment, and coaching based on the needs of both individual field-based personnel and the regional teams. The Training Manager works closely with the DFM and the Regional Associate Directors to support training initiatives as appropriate. The Training Manager works closely with Global Monitoring Operations (GMO) Training Manager to ensure alignment of US CPO and Global Training Initiatives.
* Assists DFM and CRA Group Head in defining and implementing the US Clinical Operations Oncology Training Strategy.
* Provide training support for the Field Monitor Orientation Program (i.e., new hires) including systems training and other on-boarding activities as appropriate.
* Coordinates regional activities of the US Clinical Operations Oncology Mentor Program for Field Monitors and the Local Lead CRA Training Program and maintains/updates documentation, manuals, etc.
* Assists DFM in managing and coordinating the IMPACT and EDC Super User Program and maintains/updates documentation.
* Coordinates and provides regional training programs based on the Clinical Operations Oncology Training Strategy. This includes training on SOPs, Working Practices, guidelines, therapeutic area/disease states, compounds, compliance topics and job aides.
* Provides additional training support through co-monitoring with Field Monitors (i.e., in-field coaching) if performance weaknesses are identified by Regional Associate Directors or to support development plans identified by the US Clinical Operations Oncology CRA Group Head, DFM or Regional Associate Director.
* Maintains appropriate number of clinical sites as determined by CRA Group Head, DFM and RAD to ensure current knowledge and expertise in site monitoring and regulatory compliance.
* Develops and maintains relationships with Global Oncology Training, US CD&MA and other Novartis training colleagues as identified by the US Clinical Operations Oncology CRA Group Head.
* Provides input to Global Clinical Operations Oncology, CQA, etc. during the SOP / Working Practice Review Process
* As a follow-up to CQA internal audits and/or FDA inspections, provides training on areas identified

as needing additional support.
* Provide support as needed the Pathlore Learning Management System (LMS) Administrator in the ongoing entry of training documentation.Minimum:
* Demonstrated competency as a Novartis Clinical Research Associate.
* Thorough knowledge of Good Clinical Practices (GCPs), FDA Regulations and clinical trial monitoring practices.
* Excellent presentation and interpersonal skills.
* Excellent organization skills with the ability to prioritize and work effectively in a constantly changing environment.
* Strong written and verbal communication skills.
* Demonstrated ability to coach colleagues at various skill, knowledge and experience levels.
* Knowledge in computer technology and ability to support company use of electronic data systems including Electronic Data Capture.
* Ability to interact with a wide range of people and build strong, positive relationships with the CRA Group Head, DFM, Regional Associate Directors, Field Monitors and other training and development staff.

Preferred:
* Minimum five (5) years experience as a Novartis CRA with a degree in a scientific or health care discipline.
* Previous training experience.
* Working knowledge of Microsoft Office (e.g., Word and PowerPoint) and Lotus Notes.