Senior Clinical Data Manager

A biotechnology company in the Bay area is in need of a Senior Clinical Data Manager to support the team for 6+ months. This company is developing innovative therapies for neurodegenerative diseases. This organization has a healthy and growing pipeline of therapies, which is keeping the team very busy with multiple studies that are both closing out and starting up. The Senior CDM will serve as a data management expert and be the lead CDM for assigned clinical studies on multidisciplinary project teams. The Data Management team works in an outsourced model and relies heavily on their CRO vendors and needs strong vendor oversight support. This is a remote opportunity. Experience Required: Minimum 8-10+ years of Clinical Data Management experience in the pharmaceutical/biotech industries working for a Sponsor company Experience with Medidata Rave highly preferred Experience as a Lead CDM with strong CRO/vendor management experience Experience supporting studies in phases I-III from start-up through close out Ability to work well in a fast-paced environment and excellent communication skills Early phase and CNS trial experience is a plus Role Responsibilities: Responsible for development of strategy, management of study timelines, and lead all DM activities for assigned studies Develop timelines and manage expectations for deliverables between internal DM team and DM vendor Manage/oversee study setup, testing and system validation for new studies Manage DM vendors, performance and timelines as well as oversee expected deliverables including but not limited to: CRF design and completion guidelines, database design specifications, data entry guidelines, DMPs, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements Work cross-functionally with internal teams

Created: 2021-11-29