Immunomedics, Inc.

Director, Data Management

US-NJ-Morris Plains
1 month ago
Job ID
2017-1023
# of Openings
1
Category
Clinical

Overview

We are seeking a Director, Data Management to provide leadership to the Data Management group and ensure the quality of all data management deliverables through compliance with regulatory requirements, applicable industry guidelines and internal Standard Operating Procedures.  This individual will provide direct supervision of Data Management staff, represent Data Management in internal and external cross-functional team meetings, meetings with external vendors, and regulatory agencies meetings. Seek continuous improvement of the quality of group’s deliverables and effective use of applicable technologies within the group and the Company.

Responsibilities

  • Responsible for data management functions in support of clinical studies including but not limited to protocol review; CRF design, development, review, and approval; clinical trials application development and validation; external vendor oversight; and all activities required to ensure a high quality, analysis-ready clinical trial database. 
  • Monitors compliance of data management activities with existing Standard Operating Procedures and addressing any compliance issues through training, development or updating of the necessary Standard Operating Procedures.
  • Review of existing Standard Operating Procedures to ensure compliance with regulatory requirements and applicable guidelines and address any gaps if any as necessary.
  • Creates thorough data quality checks and data review strategies to ensure integrity of the clinical data.
  • Develops and provides study tracking and metrics tools to improve monitoring of study progress and data quality.
  • Coordinates and prioritizes all data management activities according to the requirements of project timelines.
  • Develops training programs to insure that all data management personnel are adequately trained.
  • Coordinates with clinical study personnel to provide timely feedback on data issues for resolution by investigational sites. Jointly with clinical study personnel, develops and prioritizes appropriate timelines for the completion of databases required for submission, report writing, and/or presentation purposes.
  • Functional management of Data Management personnel.

Qualifications

  • Bachelor of Science degree(s) in area(s) related to one of the following: life sciences (e.g., biology, chemistry), health sciences, computer science, statistics, or mathematics.  Master’s degree strongly preferred. 
  • At least 10 years of related clinical data management experience with some prior experience at the supervisory/managerial level preferably in a biotech, pharmaceutical, and/or CRO environment.  Experience must include strong working knowledge of data management practices; strong expertise in data capture; knowledge of SDTM models and experience in transforming raw data into approved standards; and familiarity with applicable US and global regulatory requirements.  Skills in programming and generation of data listings and summary tables using SAS and other languages would be helpful.
  • Thorough understanding of all aspects of the data management functions including CRF development, query resolution, medical coding, and all activities associated with database lock.
  • Good working knowledge of EDC technology. Experience with initial implementation of EDC applications is not required but is highly desirable.
  • Thorough knowledge of applicable regulations, ICH guidelines, CDISC requirements and models such as SDTM, and clinical/scientific terminology common to biopharmaceutical setting.
  • Experience with developing data capture standard. Familiarity with CDASH is desirable.
  • Previous experience with direct supervision of data management personnel in the pharmaceutical/biotechnology or CRO industry is required.
  • Excellent interpersonal skills and problem solving capabilities. Strong project management and mentoring/leadership skills.
  • Strong organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.
  • Good verbal and written communication skills.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed