Job Description:

At Scipher Medicine, we are revolutionizing the way medical treatments are prescribed. Leveraging our innovative platform, we ensure patients receive the treatment that matches their unique biological makeup. Our goal is to optimize treatment from day one and drive novel target discovery to cater to patients who remain unresponsive to existing therapies. To achieve this, we are looking for a data scientist skilled in data pipeline development, database management, and cloud computing to join our team.The RoleThe Senior Clinical Trial Associate candidate will be responsible for supporting clinical studies while effectively organizing and assisting in the start-up, implementation, management and close-out of our clinical trials.What will I do?· Provide overall program support to the Clinical Operations team as well as liaise with other internal and external collaborators· Assist with the drafting or review of study specific documents and plans such as informed consent forms, site training manuals, regulatory documents etc.· Ensure study contact lists, metric trackers, checklists, and systems are up to date· Assist with the development of the electronic case report form by providing reviewinput with clinical research, protocol, and site perspectives· Participate in monitoring visits, as needed· Plans site and CRA trainings· Acts as a liaison and resource for clinical trial sites· Track clinical data entry expectations against monitoring activities and performance in preparation for data review meetings, data cuts, regulatory submissions, etc.· Collaborate with vendors and CROs· Manage the TMF by overseeing document collection and filing, ensuring compliance with the TMF plan, and performing periodic QCs· Communicate with CROs and study sites to drive successful trial completion· Assists in the development of timelines; tracks performance to forecasts· Play a key role in the review of study specific data review· Plan study related meetings and draft meeting agendas and minutes· Effectively communicate trial details to ensure that all team members are kept informed· Properly elevate particular situations with understanding of action items and their impact on the present & future· Participate in the development and review of SOPsMinimum Education and Qualifications· Bachelor's degree in a relevant field· 5 plus years' experience within a Clinical Operations team· Prior experience managing sites and being directly responsible for their performance at the Sponsor level· Experience in diagnostic development trials a plus· Solid knowledge of Good Clinical Practice (GCP) and the Code of Federal Regulations (CFR) is required· Broad knowledge in clinical monitoring activities, site management and essential site documents· Ability to work within a matrix team environment· Strong communication skills, both written and verbal· Ability to laugh at yourself· 75% travel requiredScipher is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law