Responsible for supporting, under the leadership of the Clinical Trial Head (CTH), all aspects of clinical trial(s) and program level activities as assigned.
Support CTH in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards.
Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools, guidelines and training materials; management of clinical study material; implementation of issue resolution plan; preparation of clinical outsourcing specifications.
Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD.
Support CTH in managing interactions with Oncology Global Development Operations, and other relevant functions including Drug Supply Management and Novartis local medical organizations.Accountable for accuracy of trial information in all trial databases and tracking systems.
Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing.May participate in the organization and logistics of various oversight or Advisory Boards.
Point of contact for managing/answering questions related to trial procedures and patients’ eligibility.
Draft CTT meeting minutes. Participate in International Clinical Team meetings. May organize and chair trial sub-teams within the scope of his/her delegated responsibilities.
Assist with program level activities (e.g., tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
Responsible for implementation of best practices and standards for trial management within the OGD, including sharing lessons learned.
Note: This position is for either a Senior Clinical Manager or an Expert Clinical Manager. The level at which this position will be filled will be commensurate with the experience of the candidate to whom the job is offered.
Bachelor of Sciences degree in life sciences or healthcare is required. Advanced degree in Sciences is preferred.
2+ years experience in clinical research including trial planning, execution, reporting, and publishing, in the pharmaceutical industry, a CRO, or biotech firm. May consider Oncology research site experience in ClinDev Phase 2-3 trials. Plus:
•Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in supporting trial planning, executing, reporting and publishing activities.
•Good communication, organization and tracking skills.
•Proven networking skills and ability to share knowledge and experience amongst colleagues.
•Proven ability to work both independently or in a team setting, and to meet set goals by managing own timelines.
•Knowledge of Good Clinical Practice; basic knowledge of clinical trial design; understanding of the overall drug development process.
•Basic knowledge of principles for trial budgeting is preferable.
•Basic knowledge of Oncology and/or Hematology preferable
Novartis - 20 months ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...