Senior Clinical Data Manager
20+ years clinical data management experience in Phase I – IV clinical studies (from study start up to database lock activities), represent sponsor at investigator meetings, perform vendors/CROs qualification and audit, vendors/ CROs management, timelines/milestones management, develop Clinical Data Management Standards (i.e. author SOPs, develop standard Case Report Forms and standardized database structure using Clinical Data Interchange Standards Consortium (CDISC) naming conventions and structure), MedDRA and WHODrug coding, support in FDA audit.
Relevant Therapeutic Areas
- Infectious Diseases
- Associate Director of Clinical Data Management
- Senior Manager of Clinical Data Management
- Greater Boston Area
- Open to remote and travel
- Small & Medium-Sized Biotechs
Skills & Accomplishments
- Worked collaboratively with the Clinical team, Biostat, Programming, and Medical Monitor throughout the study cycle.
- Represented data management in the study Investigator’s Meeting to train clinical site personnel and clinical research associates.
- Experience with start-up activities including protocol review; CRF design; review database set up and UAT (user acceptance testing); draft, review, and approval of data management documents such as edit checks specifications, data management plan, study timelines, and deliverables, coding guideline, SAE reconciliation guideline, SOW for data transfer, etc.
Tools & Systems
- Oracle Clinical RDC and InForm
- Integrated Review
- basic SAS programming
- Microsoft Office (Excel, Word, Project, PowerPoint, Publisher)