UNITY Biotechnology is a nascent integrated biopharmaceutical company discovering and developing medicines to treat chronic diseases associated with aging. We are located in the San Francisco Bay Area and are seeking to hire a Clinical Project Manager (CPM). The CPM will be responsible for providing clinical project support for a given Clinical Program within UNITY’s Senolytic Drug Development Program. In addition, the successful candidate will collaborate with the Head of Clinical Operations and Chief Medical Officer to facilitate attainment of the translational research goals of the Clinical Development Plan. The position provides vital support for clinical systems infrastructure and clinical administrative and organizational needs. In addition, the CPM will ensure that clinical implementation methodology is conducted in accordance with Good Clinical Practice, applicable rules and regulations, ethical standards, and UNITY’s Standard Operating Procedures and guidelines. The CPM will provide programmatic support that may include but not be limited to the following activity:
- Developing clinical plans, timelines and budgets
- Managing all operational aspects of trial implementation, including ensuring compliance with GCP, SOPs, and Regulatory requirements
- Developing Clinical Protocols and associated documentation, such as Informed Consent Forms (ICFs), eCRFs, Data Capture Tools (Patient Reported Outcomes), and technical study manuals
- Managing regulatory and core clinical documentation (Trial Master File)
- Overseeing Quality Management as it pertains to a given trial or program
- Managing clinical strategic outsourcing, including vendor selection and oversight, and development of the vendor management plan
- Managing Central Laboratories and working with the Translational Research team to support the Biomarker Plan.