Sr. Clinical Manager, Oncology Clinical Development, CTMR

Job description

Job Description

Support clinical trials and program level activities as assigned, under leadership of Clinical Trial Head in Oncology Clinical Development (OCD), Clinical Trial Management and Resources (CTMR). Ensure multiple trial deliverables are met according to timelines, budget, operational procedures and quality standards for assigned Non-Small Cell Lung Cancer trials. Coordinate preparation for Global Medical and Operational feasibility meeting to allocate Global Clinical trial in countries. Review clinical trial data from global perspective to ensure data quality and accuracy. 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; and preparation of clinical outsourcing specifications. Apply expertise in solid tumors pipeline and molecular biology to support protocol development and data review. Monitor Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget. Support development, management and tracking of trial budget, working closely with appropriate partners in Oncology Global Development (OGD). Accountable for accuracy of trial information in trial databases and tracking systems. Support Data Manager in electronic case report forms (eCRFs) creation for the Oncology clinical trial. Contribute to ongoing scientific review of clinical data and support trial data analysis, reporting and publishing. Serve as point of contact for questions related to trial procedures and patients' eligibility. Coordinate preparation for Global Investigator's Meeting to train Clinical Research Associates, Investigators and Site Staff about the Non-Small Cell Lung Cancer clinical trial. Assist with program level activities as assigned (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 database management for proprietary ClinAdmin clinical trial management system for Global Oncology Clinical Trial.

EEO Statement

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.

Desired profile

Must possess Master's or foreign equivalent degree in Life Science or Healthcare field and minimum 2 years of industry experience in global clinical research for oncology, supporting trial planning, execution, reporting and publishing. Must have expertise in solid tumors pipeline and molecular biology required to support oncology protocol development and data review; experience in electronic database management for clinical trial management system; budget and contracts review; knowledge of clinical trial design & understanding of drug development process; demonstrated understanding of GCP; and proven ability to work with cross-functional, multicultural and international clinical trial teams.