The Principal Trial Manager is responsible for leading projects and initiatives to improve the quality and compliance of the data management functional areas in addition to the regular responsibilities as an individual Trial Manager. Will interact with Trial Managers as SME, Mentor and Trainer within areas of expertise and provide project leadership to help develop knowledge within the department. Will be able to work independently or as a team member or leader with equal effectiveness. The Principal Trial Manager is responsible and accountable for the successful execution of the clinical data management strategy for one or more drug or vaccine trials within the TM role. Will be responsible for leading and/or representing data management functional areas in cross-functional initiatives and project teams as deemed appropriate. Principal Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives.
Education/Experience
B.A. or B.S. degree,
preferably in life sciences, computer science, or related discipline, with at least 6 years’ experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years’ experience working with formal project management tools and processes.
Knowledge And Skills
- Experience in Oncology Therapy Area is required.
- Demonstrated accomplishments through all phases of the Study Life Cycle.
- Proficient overall working knowledge on the clinical development process.
- Knowledge of applicable regulations and policies.
- Be able to work under pressure in a changing environment with flexibility.
- Ability to work independently and accept and act with appropriate accountability with minimal guidance by management.
- Ability to coordinate the work of others and drive decision making.
- Exceptional communication skills (oral and written) with the ability to comm