Lead Clinical Data Manager

Company: DFS Pharma
Location: Wilmington
Posted on: December 2, 2019

Job Description:

Lead Clinical Data Manager (Must be either Wilmington, NC or Boston, MA area) Lead Phase I - IV Data Management teams comprising internal and external data management resources. Manage clinical trial data or data management projects under aggressive timelines in a high quality and professional manner. Identify requirements for the capture and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required.
Solid understanding of all aspects of clinical data management required:- Experience as lead DM of a Phase III study required; ability to be primary contact for clients with little oversight required- Perform as lead over projects- Responsible for adhering to client timelines and budget- Perform as DM lead overseeing client's Data Management vendors - create and/or review and approve all DM documentation- Full DM operational responsibilities - listing review, query generation and resolution, external data processing- Creation of Data Management Plans and eCRF completion guidelines- Understanding of Database Build Specification documents- Testing (UAT) of EDC databases- Create and manage data management timelines for selected programs Bachelor's Degree or equivalent. A minimum of 5 years experience in clinical data management required. This position can be remote based. Excellent potential ground floor opportunity for someone with entrepreneurial spirit.Knowledge of, and experience with EDC databases, CDISC standards, medical terminology, and quality control processes.Familiarity with GCP, ICH and FDA requirements as they apply to Clinical Data Management. Regular interaction with Clinical Operations, Biostatistics, Project Management and Quality Assurance groups. Must be able to manage multiple initiatives and shifting priorities within a small company environment. Excellent written and oral communication skills required. Occasional travel required.

Keywords: DFS Pharma, Wilmington , Lead Clinical Data Manager, Executive , Wilmington, North Carolina