Clinical Data Manager

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Clinical Data Manager

  • Specialty:

    Scientific
  • Title:

    Clinical Data Manager
    • City:

      Boston
    • State:

      MA
    • Zip Code:

      02210
  • Start date:

    06-17-2019
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    49766

Description

POSITION SUMMARY:  Responsible for managing all aspects of clinical data management activities for clinical programs which could span across start-up, ongoing, and database lock activities, including projects that have been contracted to CROs as well as internal paper or EDC projects.

ESSENTIAL FUNCTIONS:

  • Ensure data accuracy and integrity in preparation for statistical analysis, ensuring the quality of data produced 
  • Participate in the development of database standards and ensure that when CROs perform data management activities that they adhere to these standards
  • Review clinical database-related output and deliverables produced by CROs on an ongoing basis to ensure database quality and integrity for CRO and Data Management
  • Develop and standardize case report form design
  • Ensure that all clinical Data Management SOPs
  • Understand and maintain documentation that SOPs are followed 
  • Compare and reconcile adverse event data captured in Drug Safety with adverse event data captured on the case report form (as applicable)
  • Review and evaluate any data received from sources other than case report forms (e.g., central laboratory data) and ensure readiness for analysis. Code concomitant medications, and other data as needed.
  • Design and produce, in conjunction with Clinical and Biostatistics, data listings for review of the accuracy, completeness and consistency of clinical trial data
  • Specify database edit checks and follow data discrepancy resolution procedures
  • Monitor timelines and ensure that deadlines are met. Participate in development and maintenance of Standard Operation Procedure (SOPs)
  • Oversee CROs in their delivery of data management milestones where appropriate; liaise with third party vendors and EDC vendors in a project manager capacity
  • Maintain familiarity with relevant clinical topics and issues
  • Regular attendance and timeliness is essential

QUALIFICATIONS:

  • Bachelor of Science degree preferred, preferably in health related field and/or computer; or some college and strong exprerience
  • 3- 6 years’ experience in clinical data management in the pharmaceutical/biotechnology/diagnostic industry
  • Experience in all phases of data management for clinical trials is preferred
  • Diagnostic experience a big plus
  • EDC experience preferred
  • Demonstrated ability to follow Clinical Data Management SOPs 
  • Coding experience with WHO Drug, ICD-9, MedDRA desirable
  • Knowledge of GCP, regulatory and ICH Guidelines as applicable to data management
  • Excellent written, verbal and organizational skills; work effectively as a team player
     

PHYSICAL DEMANDS:

The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.

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