System One Services Associate Director Clinical Data Management in Worcester, Massachusetts
Associate Director Clinical Data ManagementWorcester, MA
Category:Scientific & Clinical
Full Time Permanent Associate Director Data Management Opportunity.
Location:Worcester, MA area
- BS degree preferably in statistics, science, math or computer programming
7+ yrs. as a Data Manager within Data Management or Clinical organization
Prior exp. serving as a Clinical Data Manager leader for early phase oncology clinical trials.
Exp. working as Data Management line function representative to Clinical Study Team
Prior exp. interacting with CROs, including direct oversight while coordinating day to day study data management activities
Primary exp. with CDMS process in the context of early phase clinical trials, working knowledge of SDTM/CDISC standards
Knowledge in medical terminology, medical coding classification system (e.g., MedDRA and WHODrug Dictionaries)
Expertise in EDC and industry standards including ICH-GCP guidelines, and CDASH/CDISC
Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management
Provides support and day-to-day contact with team to handle data management questions, troubleshoot, help resolve issues and mitigate risks
Develop or oversee vendors and/or consultants in data management services, database development and eCRF design, UAT, data entry guidelines, data management plans, reports, manuals, and related operations.
Work collaboratively with clinical sites and internal team members to ensure data is collected, managed and reported clearly, accurately and securely
Track and report data management activities; data timelines, key deliverables and project status ensuring industry standards related to clinical data collection, processing and quality
Responsible for executing or overseeing data cleaning activities, including oversight of generating and managing clinical trial data queries, coding specified clinical trial data (e.g., adverse events and concomitant medications) and data reconciliation (e.g., SAE and vendor)
Manage external data transfer protocols and standards to ensure deliverables adhere to industry best practices and deliver high quality output in line with agreed timelines
Accommodate ad hoc data requests between clinical team members, scientists, and vendors to support data cleaning, data entry requirements and exploratory data review
Provide input and participate in the development of clinical study documents including protocols, clinical monitoring plans and statistical analysis plans
Assess system performance and make recommendations for new software, hardware, and data storage improvements