Heather Prentice Email & Phone Number

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana Area

In this role I provide direction, leadership, and technical/process expertise to individual global study managers supporting oncology trials. My responsibilities include clinical operational oversight of regional/global trial level deliverables including enrollment targets while ensuring regulatory compliance and clarity in implementation of the process. I support an environment where performance and results are valued and my direct reports grow developmentally and have opportunity for advancement. Key competencies include; Business planning, resource management, trial management technical expertise, training and compliance, process improvement, cross functional communication, and performance management.

Clinical Project Management - OncologyUse project management skills, processes and tools to develop and execute global clinical trials.Maintain knowledge of sourcing strategies and provide third party organization oversight.Leverage expertise to identify areas of process breakdown, assess situations and propose approaches that impact ability to delivery the clinical trial - with quality, on time and within scope and budget.Report, manage and interpret information for the trials, including completeness and accuracy across multiple business systems and tools. Demonstrated understanding of drug development process.Knowledge of global regulations and GCP to achieve inspection readiness.Scientific knowledge and process expertise to impact clinical trial design, feasibility and implementation.

As Director of Research Development, I oversee the development of oncology clinical trial protocols through collaborative research agreements with key scientists and thought leaders within our member network and emerging biotech and pharma companies across the United States and abroad. This includes writing and editing concept proposals, protocols for clinical trials, and other documents related to clinical trials and developing clinical trial budgets for negotiation with funders. Management of clinical trial subcommittees consisting of community and academic representatives who specialize in the areas of Quality of Life, Breast, Gastrointestinal, Gynecology, Urology, Hematology, Thoracic (Lung), and Translational/Correlative research. Assign and coordinate activities of trial development to ensure protocol, regulatory and standard operation procedures and Good Clinical Practice compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.

As Coordinator of Protocol Develoment, my responsibilities included working with physician scientists to assist in developing, writing and producing clinical trial protocols from letters of intent through regulatory approval. Registered and reported clinical trial information and data to required trial registries. Liaison to internal administrative departments including; Biostatistics, finance, regulatory, scientific review committees, grants and contracts personnel, as well as Industry representatives. Facilitated the design, development, review and conduct of investigator sponsored studies at IU Simon Cancer Center and affiliates.