• Clinical Data Manager - Plymouth Meeting

    Job Locations US-PA-Plymouth Meeting, PA. USA
    Job ID
    2017-2414
    Category
    Management
    Position Type
    Permanent Employee - Full-Time
  • Position Summary

    Clinical Data Manager - Plymouth Meeting, PA

     

    You will need to evidence extensive Clinical Data Management.

     

    Reporting in to the Director, Data Sciences, this role will be based out of Plymouth Meeting. We now have one Data Manager in place and recruiting a second one. 

     

    The Data Managers are responsible for managing and coordinating all aspects of the study specific data management processes, in support of any assigned studies’ Statement of Works (SoW). Responsibilities include planning, development and maintenance of the Data Management Plan (DMP), coordination of the Data Coordinators and Data Reviewers for data management monitoring and cleaning activities, and specifications for study specific reports based on the DMP. All changes to the eCOA database are managed in line with the company’s quality management system and supported by the appropriate study documentation to guarantee compliance with regulatory authorities and/or the company’s Sponsors.

     

    The Data Manager will act as the primary internal and Sponsor contact for Data Management inquires during the study setup and study maintenance phases.

     

    Do view the benefits on offer at CRF Health

    Responsibilities

    • Develop and maintain the Data Management Plan (DMP).
    • Develop and maintain study-specific Data Cleaning/Reconciliation reports and validation plans.
    • Provide weekly data management status updates to the clients and internal Project Managers.
    • Collaborate with clients and internal Delivery teams to develop and maintain protocol specific monitoring report specifications.
    • Collaborate with clients and internal Data Coordinators and Data Reviewers to generate a study-specific tool for flagging discrepancies between the client IVR/EDC and TrialManager outputs.
    • Work with internal Delivery team to define data management timelines to ensure DM milestones are met.
    • Develop other study-specific documentation manuals including but not limited to the Maintenance Guide (MG) as necessary.
    • Conduct study-specific trainings with internal Data Coordinators and Data Reviewers prior to release of the Data Management Plan initiatives.
    • Collaborate with clients and internal Technical Client Services team in order to conduct protocol reviews to identify protocol specific device design and eligibility criteria.
    • Collaborate with clients and internal Technical Client Services team to define protocol specific report(s) as necessary.
    • Collaborate with internal validation team to define detailed test cases for clinically significant reports.
    • Adhere to CRF Health Standard Operating Procedures for all data management responsibilities.
    • Identifies areas of opportunity for improvement in the end to end process of Data Management, driving out waste, increasing productivity and delivering quality
    • Supports delivery of improvements in the Data Management process by participating in small group activities, kaizen events and Lean Six Sigma projects when necessary
    • Other responsibilities will be assigned as required.

    Requirements

    • Minimum education: Bachelor’s degree in Science related field or related experience.
    • Minimum of at least three, 3 years’ data management and/or related work experience in a medical device or pharmaceutical industry/company.
    • Must have experience with Electronic Data Capture and/or other data management services.
    • Working knowledge of Good Clinical Practices, Good Clinical Data Management Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
    • Ability to operate within cross-cultural, multi-disciplinary teams and therapeutic areas.
    • Ability to multi-task and effectively set own priorities.
    • Must have excellent communication and written skills.
    • Must have solid basic MS Tool experience – Word, Excel, with MS Project, PowerPoint preferred.
    • Must be able to communicate effectively with Delivery Teams, internal and external Data Management and Clients.
    • Must be a team oriented person with a “can do” attitude.

     

    About CRF Health

    Global Leader in eCOA Solutions for Clinical Trials 

     

    CRF Health is a global leader in eCOA (electronic Clinical Outcome Assessments) solutions for the life sciences industry. eCOA encompasses PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes) with outstanding project management focused on delivering value for our customers.  Committed to driving the change to higher quality outcomes and more efficient paper-free clinical trials through improved patient engagement, our intuitive and patient-focused eCOA technology helps companies bring new medicines to market quickly, safely and more cost-effectively. Our complete eCOA solutions are ideal for home and site-based phase I-IV clinical trials across the world for many therapeutic areas and patient populations.  More information to be found on our website.  

     

     

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