ZOLL Circulation, Inc.

  • Sr. Clinical Data Manager

    Job Locations US-CA-San Jose
    Posted Date 2 months ago(12/9/2018 10:46 AM)
    Job ID
    # of Openings
  • Overview

    General Summary:

    Responsible for the creation, updating, maintenance and validation of clinical study databases and for the provision of computerized reports of these data. Assumes the responsibility for management of clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, industry and regulatory agency guidelines.


    Essential Functions:

    Project Management:

    • Provide data management / data entry / verification / validation / quality control of data collected for worldwide Clinical Trials consistent with applicable regulations, guidelines and policies
    • Oversee proper collection of data and participate in the development and maintenance of computerized data collection system
    • Understand all relevant data standard including FDA Safety & Innovation Act of 2012 (FDASIA), CDISC / CDASH compliant data standards
    • Manage data cleaning process
    • Participate in study start-up and study conduct
    • Ensure conformance with GCP
    • Lead subordinates by developing, communicating, and building consensus for goals and programs that support division and company objectives
    • Investigate and solve problems that impact work processes and personnel in multiple departments
    • Skillfully develops, nurtures and maintains relationships
    • Able to brief management on trial results or status
    • Evaluate performance and assist in career development planning for subordinates

    Study Related Material Development and Review

    • Contribute to case report form development and approval
    • Prepare, review and approve Data Management plans and reports
    • Assist with development of Monitoring Plan
    • Lead EDC development
    • Assist in development and implementation of strategy for data cleaning and in the design of clinical databases
    • Generate data retrieval and complete reports as required

    Site/CRO/Investigator Management

    • Lead database related activities between sponsor and Contract Research Organizations (i.e. CROs, core labs)
    • Conduct audits of CROs and other outside vendors as necessary
    • Query data for inconsistencies and communicate with sites for query resolution

    Training/Scientific Meetings/Other Duties As Assigned

    • Familiarity with Clinical Data Management industry standards (i.e. CDASH, etc.)
    • Adheres to current Good Clinical Data Management Practices Guidelines (GCDMP)
    • Assist with the training of CRAs, Consultants, and Contract CRAs
    • Participate in the development, review and approval of departmental SOPs
    • Attend relevant scientific/medical meetings as needed
    • Responsible for other duties and projects as assigned

    General Departmental Responsibilities

    • Confers with Manager, Data Management, Senior Director, Clinical Affairs and other management staff regularly to review internal progress and external conditions and discuss required changes in goals or objectives resulting from current status and conditions
    • Comply with ZOLL Circulation’s quality system requirements as well as any applicable regulatory requirements
    • Maintain up-to-date knowledge of global medical device regulations
    • Interact with equivalent level intra- and inter-organizational management and staff concerning matters of significance to the company


    Skill Requirements:


    • Analytical – Ability to analyze complex or diverse information; collects and researches data; uses results, intuition and experience to synthesize product specific direction
    • Design - Generates creative solutions; demonstrates attention to detail
    • Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations
    • Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions
    • Written Communication – Writes clearly and informatively; presents numerical data effectively; able to read and interpret medical, scientific and engineering literature
    • Organizational Support - Supports organization's goals and values
    • Adaptability & Dependability – Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals
    • Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
    • Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence


    Education/Training/Experience Requirements:


    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



    • Must have relevant experience developing and maintenance of clinical data management programs and databases
    • Minimum 5 years in relevant work
    • BS degree in related area
    • Prior people management and clinical data management experience required


    Language Ability:

    Ability to read, analyze and interpret complex documents. Ability to respond effectively and appropriately to the most sensitive inquiries or complaints. Ability to develop presentation materials and deliver presentations at investigator and departmental meetings as necessary.


    Reasoning Ability:

    Ability to define problems collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.


    Computer Skills:

    Working knowledge of desktop computer and standard database software programs. Experience with various Electronic Data Capture platforms a must.


    Certificates and Licenses:

    No certifications needed.


    Supervisory Responsibilities:

    Manages subordinates in the Clinical Affairs Department and is responsible for the coordination and implementation of the projects within the unit. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing and training employees; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems.


    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.


    Physical Demands:

    The physical demands described here 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 frequently required to travel regularly. The employee is regularly required to sit, talk and hear. The employee is regularly required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus. Ability to work in an engineering and animal laboratory for extended periods is essential.


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