BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Clinical Data Manager to work for a leading San Diego biotechnology company.
Clinical Data Manager
Description: Under general supervision, the Clinical Data Manager will be part of the Data Management team responsible for study specific data management activities, including study set-up, maintenance, data review and clarification.
Essential Duties and Responsibilities:
Review protocols and provide input relevant to data management issues
Oversee all data management activities within CROs and database build/maintenance within EDC vendor
Manage external lab vendors, transfer specifications, and transfer timelines
Review/create study specific data management documentation (i.e. Data Management Plans, Database Specifications, Edit Check Specifications, clinical data query handling and resolution, Vendor data Reconciliation Plans, SAE Reconciliation Plans, etc.)
Perform User Acceptance Testing of EDC system
Perform/oversee clinical study data maintenance, data listings, enter queries, review query resolutions, etc.
Perform Validation of SAS programming within Data Management
Provide input on general data management documents such as SOPs, standards, templates, etc.
Education: Bachelorâ€™s Degree in Life Sciences or Mathematics and/or four to six years of experience in clinical data management on-the-job training in clinical trial methodology and Good Clinical Practice
Experience: Must have a basic to moderate understanding of all aspects involved in the data management responsibilities throughout a clinical trial; appropriate experience with an understanding of at least one clinical data management system (e.g., Medidata Rave, Inform, Clintrial); good organizational and documentation skills; a general understanding of regulatory guidance and regulations (e.g., ICH, 21CFRpart11, etc.); and be a team player who works effectively with other disciplines
Local Candidates Strongly Preferred