Responsible for operational aspects of one or more clinical trials (phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use) under the leadership of the CTH. Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned with an entrepreneurial approach which requires the ability to multi-task on a wide spectrum of activities with an overall external focus
1. Contributes to or manage simple clinical trial with minimal supervision by providing input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepare training materials and presentations related to the planning and conduct of the trial.
2. Manage simple clinical trial under supervision from the senior clinical operations team. Write CTT meeting minutes. May deputize for the CTH at certain meetings. Ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures and quality standards, SOPs and Business Guidance.
3. Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing.
4. Assist in preparation of clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget
5. Support the development, management and tracking of trial budget working closely with the appropriate partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
6. Contribute to the development of clinical sections of regulatory documents like Investigators Brochures, safety updates, etc....
7. Participate in the on-boarding and training of new staff. May serve as faculty member for training programs
8. Responsible for MRC process as directed by GMA medical lead. Contribute to the management of third-party Investigator Initiated Trials (ITT), Regional and Locally Sponsored Novartis Trials provide feedback on study proposals, review submitted study concepts/protocols for core requirements via the Study Express System. Collaborate with local CPOs and regions to track study progress, update databases and manage budget. Ensure compliance with Novartis SOPs, Business Guidance and regulatory requirements
9. Support Individual Patient Support Program as assigned. Manage physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply.
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 health or life sciences.
Fluent English oral and written skills
3 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
Proven ability to work independently and ability to collaborate and work effectively in teams.
Demonstrated ability to support more than one clinical trial
Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required
Basic knowledge of hematology/oncology/endocrinology therapeutic areas is preferred
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.