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    Clinical Data Manager - Ontario, Canada - Collage HR

    Collage HR
    Collage HR Ontario, Canada

    1 week ago

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    Description

    We are looking for an experienced Clinical Data Manager to support ongoing growth in our Data Management department. The role can be remote (home-based) anywhere within Canada.

    The Clinical Data Manager will perform data management activities at all stages of assigned projects such as start-up (CRF design, EDC build & validation, training, DM planning), execution (data cleaning, metrics tracking, running listings, SAE reconciliation, medical coding, document management) and closeout (database lock and data transfer).

    • Are you a team player striving for continuous improvement?
    • Are you driven by high quality clinical data and ensuring excellent service to your customers?
    • Do you enjoy being faced with a challenge and troubleshooting innovative solutions?
    • Are you flexible and able to adapt to an evolving and dynamic work environment?
    • Are you interested in exposure to other functional areas, to better understand how your role fits into the bigger picture?
    • Do you want to make an impact and be recognized for your contributions?

    If you have answered YES, we encourage you to apply

    Responsibilities:

    • Provide data management expertise to both internal and external stakeholders
    • Data Management project planning and risk management
    • Create and implement Data Management Plans that will ensure delivery of quality clinical data in a timely and efficient manner (developed in collaboration with the Clinical Study Manager)
    • Develop Case Report Forms (CRFs), EDC database design and annotate CRFs
    • Create and test system edit & data validation checks, oversee User Acceptance Testing
    • Generate CRF completion Guidelines (CCGs), and deliver EDC training as needed
    • Identify potential data management issues, initiate preventative measures, and escalate issues appropriately.
    • Collaborate with cross-functional study team members (clinical operations, biostatistics, drug safety, etc.) to define the necessary listings needed for the support of clean-up, validity, and summary tables
    • Run SAS programs to generate complex listings, tables and complex graphs
    • Data cleaning and discrepancy management.
    • Medical coding (with oversight by medical monitor)
    • Track and report on metrics, status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
    • Oversee the freezing and locking of data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock
    • Accountable for the high-quality output on assigned data management deliverables as per the established timelines.
    • Carry out assigned data management activities in strict compliance with applicable study plans, SOPs, regulatory and GCP standards.
    • Actively participate in the generation and/or review of relevant SOPs & working instructions
    • Recommend and drive continuous improvement of processes, systems and tools to enhance the data management function and increase efficiency
    • Implementation of global standards related to clinical study data management activities.
    • Participate and/or complete internal and external training within specified timelines
    • Support achievement of data management revenue and gross margin targets
    • Develop and maintain strategic client relationships
    • Support proposal development with data management time and cost estimates and prepare and present to potential clients on data management capabilities
    • Fulfill other duties as required
    • In-depth knowledge of ICH-GCP guidelines and applicable regulations
    • Ability to communicate complex data management concepts to non-data managers
    • Understanding of CDISC, CDASH, SDTM, ADaM, XML
    • Meticulous, high level of attention to detail, autonomous and able to work with minimal supervision
    • People management skills (collaborative, positive, empathy)
    • Project management skills & financial acumen with respect to managing study budgets
    • Effective time management skills and ability to manage competing priorities
    • Customer focused, analytical and a problem solver
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients
    • Proficiency in Microsoft Office applications, specifically Word, Excel, PowerPoint and Outlook
    • Previous experience in the implementation of global standards related to clinical study data management activities preferred
    • Strong English communication skills (oral, written and presentation), French is an asset
    • Proficiency with iMedNet (asset)
    • SAS programming (asset)

    Qualifications:

    • Undergraduate university degree (science or related major preferred), relevant work experience may be considered as equivalent qualification.
    • A minimum of five (5) years of pharmaceutical or CRO experience, including two (2) or more years specifically in clinical data management.
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