Responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.
• Provide 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.
• Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
• Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and client local medical organizations.
• Accountable for accuracy of trial information in all trial databases and tracking systems.
• Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD..
• Participate in the organization and logistics of various oversight and Advisory boards; attend meetings.
• Point of contact for managing/answering questions related to trial procedures and patients' eligibility.
• Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. May participate in International Clinical Team meetings.
• Contribute to 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 TA, including sharing lessons learned.
• Contribute to talent and career development of OGD staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for OGD training programs.
Qualifications
Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
Proven networking skills and ability to train colleagues.
Proven ability to work both independently or in a team setting, including a matrix environment
Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
Knowledge of principles for trial budgeting.
Basic knowledge of oncology and/or hematology preferable
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