Senior Clinical Data Management Leader
20+ years clinical trial 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, forecast and update study/program budget, clinical site set up/training and monitoring, develop Clinical Data Management Standards.
Relevant Product Types
- Small Molecule
- Monoclonal Antibodies
- Gene Therapies
Relevant Therapeutic Areas
- Infectious Diseases
- Senior Director of Clinical Data Management
- Executive Director of Clinical Data Management
- Senior Data Manager
- Greater RTP 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.
- Interpersonal communication (include negotiation skills and conflicts resolution), public speaking, and presentation skills
Tools & Systems
- Oracle Clinical RDC and InForm
- Integrated Review
- basic SAS programming
- Microsoft Office (Excel, Word, Project, PowerPoint, Publisher)