Expert Clinical Manager III
Conduct operational aspects of global oncology clinical trial(s) under the management of the Clinical Trial Head (CTH) and also manage tasks independently. Support scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.
1. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures, quality/compliance and performance standards under the management of the CTH. 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; oversight of vendors and other third parties; implementation of issue resolution plan; conduct clinical data review.
2. Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
3. Support the development, management and tracking of trialbudget as assigned, working closely with the appropriate partners in Oncology Global Development (OGD and GMA).
4. Manage interactions with relevant line functions including Data Management, Drug Supply Management and Novartis country organizations under the direction of the CTH. Attend Clinical Trial Team (CTT) meetings, participate and report study progress and issues/resolution plan at the Clinical Trial Team meeting.
5. Responsible for accuracy of trial information in all trialdatabases and tracking systems.
6. Responsible for the ongoing scientific review and validation of clinical data (member of the Data Review Team).
7. Participate in the organization and logistics of various trial-related committees.
8. Point of contact for managing site-related issues and procedural questions. Support CTH in development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis.
9. Write CTT meeting minutes. May occasionally deputize for the CTH to facilitate CTT meetings. May participate in International Clinical Team meetings (ICT). Organize and chairtrial subteams within the scope of his/her delegated responsibilities.
10. Prepare training materials and presentations related to the planning and conduct of the trial.
11. Contribute to program level activities (e.g., development of clinical sections of regulatory documents such as Investigators' Brochures, DSUR/PSUR, IND/NDA submission documents) and provide support, as needed, for HA and/or IRB/IEC inquiries.
12. Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within OGD demonstrated capabilities in
supporting operational aspects of clinical trial related
Excellent communication, organization and tracking
skills. Strong operational skills and demonstrated
ability to meet timelines.
Proven ability to work either independently or in a
team setting, to meet goals by managing compliance,
budget and timelines.
Proven networking skills and ability to train colleagues.
Knowledge of Good Clinical Practice; comprehensive
knowledge of clinical trial design; understanding of the
overall drug development process.
Basic knowledge of oncology, haematology,
endocrinology or any appropriate therapeutic area is
Advanced (e.g., Masters) degree or equivalent
education/degree in life science/healthcare is strongly