Senior Data Manager

Covance Raleigh , NC 27601

Posted 4 months ago

Job Overview

Global Specimen Solutions (GSS) at Covance is a high profile, innovative and rapidly growing business line that is charged with creating world-class, innovative technology solutions to improve the speed, cost and quality of drug development and help pharmaceutical and biotechnology companies bring the miracles of medicine to the people in need faster.

The Senior Data Manager will support clinical trial proposals and clinical trial data management. Will be responsible for supporting data management functions, including programming, testing, and day to day data management of prospective observational studies and clinical trials, while providing input on project schedules. This position will be based out of our Raleigh site or remote.


Responsibilities General Data Management

Responsibilities:
  • Work collaboratively with colleagues and takes a technical lead to develop, evaluate, validate, implement, and maintain data collection systems and technology (either internally developed or subcontracted)

  • Develop request for proposals, participates in the evaluation and selection of data collection and data management vendors. Provide input on data management policies, guidelines and procedures (SOPs, training manuals, etc.) and complies with standard operating procedures (SOPs)

  • Represent Data Management in cross functional meetings

  • Participate in business development activities, including meetings with prospective clients

Project Related Responsibilities:

  • Work with project teams to design CRFs and eCRFs for data acquisition and data entry

  • Develop and maintains auditable data management project documentation (e.g. data management plan, user acceptance testing, data quality plans, annotated CRFs, data entry guidelines, etc.)

  • Establish data and work flow plans

  • Develop test cases and performs user acceptance testing of data capture and management systems

  • Ensure database accuracy according to departmental operating procedures

  • Perform a QC review of the data and coordinates corrections to the database with the study sites

  • Follow up on query responses and errors identified in data cleaning

  • Analyze and resolve discrepancies in data validation or other reports

  • Review data listings for consistency and accuracy of data

  • Perform independent reviews of data management deliverables following documented guidelines

  • Produce project-specific status reports for management and sponsors

  • Monitor study metrics

Education/Qualifications

Bachelor's level degree in health information management, clinical, biological, or mathematical sciences or related field

Experience

  • 5 years of data management experience in a professional environment, preferably within a clinical or medical data environment or pharmaceutical company

  • Direct experience working on Phase 2, 3, or 4 clinical trials; prospective observational studies

  • Experience managing multiple simultaneous projects

  • Knowledge of FDA and EU/EMA regulations with respect to data quality and data privacy for the conduct of observational and clinical studies in the US and Europe. Thorough knowledge of the relevant ICH and GCP guidelines

  • Demonstrated working knowledge of multiple clinical data management systems and electronic data capture systems (e.g., OpenClinica, Medidata Rave, Qualtrics, etc.)

  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations

  • Good written and verbal communication skills in English

  • Must be able to set and meet timelines or be able to recognize and schedule changes in response to project demands

  • Ability to maintain a high degree of confidentiality with study data and client's proprietary information

  • Demonstrated organizational and analytical/problem-solving skills Strong attention to detail and skill with numbers

  • Ability to work productively with minimal supervision

  • Strong customer focus and excellent interpersonal skills Demonstrates judgment in making decisions

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