8-10 years in clinical data management with direct sponsor experience in small to midsize pharma/biotech companies
Experience in outsourced CRO oversight
Lead DM for Phase II/III studies in the last 3-5 years with hands-on willingness
Expertise with Medidata RAVE
Requirements:
Act as Lead Data Manager on assigned studies, overseeing CRO and owning all aspects of the data management lifecycle
Standardize and manage the clinical data flow to deliver data for analysis
Serve as main point of contact for CRO and in-house team, ensuring timely, high-quality deliverables
Ensure data quality and coordinate with other functional areas to support study milestones
Job description
Responsibilities:
Act as the Lead DM on assigned studies, providing oversight of the CRO and owning all aspects of the study lifecycle as it relates to Data Management
Standardizes and manages the clinical data flow process to data delivery for analysis purposes.
Be the main point of contact for the CRO and in house team, communicating and managing timelines effectively ensuring work is completed on time and at high quality
Ensure data quality in support of clinical study data milestones and deliverables.
Interacts and manages relationships with other functional areas to ensure high quality data management activities.
Requirements:
8-10 years working in clinical data management and specific experience working for small to midsize pharma/biotech companies (must have direct sponsor)
Must have experience with outsourced CRO oversight experience
Experience as a Lead DM for Phase II and Phase III studies within the last 3-5 years, with the willingness to work hands-on
Expertise with Medidata RAVE
Strong communication and organization to manage DM timelines, deliverables etc
