Clinical Data Manager

Found in: Jooble CA O C2 - 1 week ago

Ontario, Canada Collage HR Full time

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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