- Develops randomization and IRT program strategy, including but not limited to solving complex issues and providing solutions for areas of process improvement when applicable.
- At the program level, coordinates the randomization, IRT and unblinding activities for clinical protocols, including interacting with statisticians, clinical staff, drug supply management and IRT vendors to assure the correct randomization is followed. As needed to support the program, coordinates the activities of other staff members.
- Acts as a centralized point of contact for IRT management , randomization schedule generation, and unblinding activities.
- Develops timelines for the program to effectively set priorities in concert with therapeutic and functional areas to meet priorities and objectives.
- Collaborates withIRT Manager for activities as appropriate, but works independently and assumes some decision making responsibilities.
- Generates randomization schedules, ensuring parameters reflect the protocol and drug supply requisition(s). Distributes patient randomization and container schedules as appropriate to Clinical Supply Operations and IRT vendors.
- Participates in Interactive Response Technology (IRT) vendor relationships to ensure appropriate randomization specifications are implemented. Leads and / or coordinates the user acceptance testing of IRT systems at the program level, ensuring patient randomization and container schedules are properly utilized. Accepts manual data edits or queries from site/protocol managers. Accepts and / or coordinates data transfers from IRT vendors.
- Supports randomization and collaborates with operational and functional areas and communicates potential barriers to achieving business objectives to IRT Manager.
- Acts as a mentor to new hires by assisting with training on department processes and procedures.
- Bachelor's degree in a science related field with a minimum of 5 years work experience preferably in a health sciences or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.)
- Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint
Ideal Candidates Would Also Have:
- Clinical Research experience
- Working knowledge of Clinical Trial Management Systems