Clinical Data Associate Specialist

2 weeks ago


Etobicoke, Canada SCiAN Services Full time
Key Responsibilities

We are seeking an experienced Clinical Data Associate to oversee CDM projects and resources to ensure the quality, accuracy, and consistency of clinical data.

Key responsibilities include:

  • Develop and design case report forms
  • Design and develop study databases as per CRF template, DB and configuration specifications
  • Create and implement custom data validation rules and checks as per Data Validation Plan
  • Perform User Acceptance Testing of databases and documentation of testing
  • Author CRF completion guidelines
  • Update control CDM documents: DMP, DVP, CCG etc.
  • Perform clinical study data review (non-medical reviews) and generate/resolve queries
  • Code AE, medical history and medications; generate queries
  • Perform SAE reconciliation and generate queries
  • Manage users in EDC databases
  • Verify database design changes done by less experienced CDAs, as requested by Project Manager
  • Review changes to clinical database performed by less experienced CDAs, based on queries, site-generated DCFs and DMP (internal resolutions)
  • Review queries and self-evident corrections proposed by less experienced CDAs
  • Review queries raised by less experienced CDAs for the coding of AEs, medical history and medications
  • Other duties as assigned
Qualifications

To be successful in this role, you will need:

  • BSc. in Life Sciences preferred, or Bachelor's degree with equivalent knowledge/experience
  • Minimum 3 years of experience in clinical data management
  • Experience with EDC systems, including Medidata Rave
  • Knowledge of Lotus Notes, an asset
  • Experience in coding AEs, medical history and concomitant medications
  • Knowledge of SAS, an asset
  • Effective communication and interpersonal skills
  • Ability to work under minimum supervision
  • Flexibility in prioritization change
What's in it for you

As a member of our team, you will have the opportunity to:

  • Play a key role in helping our clients and the industry shape the future of drug development
  • Work in an environment designed for entrepreneurial-minded individuals with a lot of energy, ideas and courage for their implementation
  • Work with and leverage the best and brightest minds in the industry
  • Be part of an exciting new chapter in SCiAN's history with high growth and opportunities to progress in Senior and Leadership positions within the company
  • Enjoy a culture of collaboration, respect and empowerment
  • Benefit from competitive compensation and work life balance


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