Sr. Clinical Data Manager

Company Name:
The Contract Lead Clinical Data Manager/Programmer is responsible for the decision-making process involving data management (DM) and/or Clinical Programming issues for Phase 1- 4 studies.
Experience in managing data management services provided by CROs (i.e., preferably in a partnership)
Ability to manage multiple, phase 1 clinical studies at a time and/or multiple, large (>500 patients), global, phase 3 clinical studies at a time
Establish detailed timelines for Rave database build and lock processes that meet study needs
Lead and participate in the review of clinical data, participate in review of analysis tables/listings/figures and patient profiles for data consistency and accuracy
Ensure clinical Rave EDC databases, external data files and resulting SDTM datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and a possible regulatory submission
Develop/utilize study metrics to monitor quality, project status, activities and budget and work with Manager to identify trends and provide updates/recommendations to Sr. Management
Generates and maintains and/or provide oversight in the creation of all required database documentation including the development of specifications, coding configuration, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and profile reporting
Ensure internal and CRO clinical systems validation documentation is complete and adequate
Provide technical support in maintenance of operational data standards library and repository (Rave)
Provide standard and custom reports for use by Clinical Data Managers to aid in data QC and surveillance
Program ad hoc SAS, J-Review, BOXI reports to meet internal customer data review and oversight needs
Participate in other key activities to support data management, clinical, medical and biostatistics as needed
Minimum Basic Qualifications:
A minimum of 10 years experience in Clinical Data Management (including 5 years as a lead CDM/ lead Database Programmer) in a CRO, Pharmaceutical or Biotechnology company
Experience with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODrug dictionaries
Experience with data browser and reporting tools such as SAS (3 years) and J-Review (3 years)
Expert knowledge of GCP as well as industry practices and standards such as the CDISC and CDASH data standardization initiatives and expectations for clinical data systems including CFR Part 11
Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as the CDISC data standardization initiative and expectations for clinical data systems including CFR Part 11 is also helpful
Ability to work independently with minimal supervision
Desired Competencies and Qualifications:
Demonstrated experience in the development of eClinical processes and procedures
Familiarity with application administration and technical support for Rave such as migration mentoring/review, reporting tools, etc.
Coordinate development of specifications, programming and UAT of data entry screens, electronic edit checks, data listings, import/ export programs, lab normal tool, Core Configuration and medical coding configurations
Demonstrated ability to initiate and develop new and more efficient database build, maintenance and closeout processes and procedures
Ability to compile, analyze and present data in a clear and concise manner
Excellent written and oral communication skills
Strong attention to detail
Minimum Basic Qualifications:
BS/BA in a scientific or programming discipline is required
Desired Competencies and Qualifications:
Master's degree or coursework toward a degree preferred
Min Salary: $0.00
Max Salary: $0.00
City: Lexington
State: MA

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