Colleen Reed
Senior Clinical Trial Associate @Intra-Cellular Therapies
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WORK HISTORY
Senior Clinical Trial Associate @Intra-Cellular Therapies
Bedminster, NJ, US
Key contributor to clinical programs, supporting multiple clinical trials. Responsible for organizing and managing important study documents and materials. Manage internal Trial Master File (TMF) and review external TMFs to ensure quality and completeness of files. Schedules and coordinates clinical project meetings; prepares agendas, presentation materials, and minutes. Compiles study materials, including study reference manuals, pharmacy manuals, and laboratory binders. Maintains versioning of all study reference materials. Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures. Generates and/or reviews, distributes study-specific newsletters. Prepares and maintains study trackers (e.g, investigators, enrollment). Organizes data and metrics for analysis by study team and senior management. Manages ancillary clinical study supplies. Participates in vendor oversight activities. Supports clinical trial registry postings (e.g, ClinicalTrials.gov). Manages and maintains team SharePoint sites, as needed. Follows established Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and all applicable regulatory requirements in all tasks. Performs other tasks as needed for successful study execution and as requested by management.
EDUCATION
Jonathan Law High School
High School Diploma, Business focus
Data Institute Business School
Certificate, Medical Office Specialist
SKILLS
ABOUT COLLEEN REED
Motivated self-starter and enthusiastic team player with strong self-directed work ethic, effective project management and communication skills, ability to gain rapid understanding of new principles and business technologies, highly adaptable to change.
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