Clinical Data Associate

5 months ago

Etobicoke, Canada SCiAN Services Full time

SCiAN Services is a rapidly growing Contract Research Organization that has a passion to solve for unmet needs in the Biotechnology/ Pharmaceutical Industry. For over 35 years SCiAN has embraced innovation when offering services in Pharmacovigilance, Biostatistics, Data Management and Custom Database Solutions.

SCiAN’s therapeutic expertise includes immuno-oncology, gene therapy, CNS, infectious disease, autoimmune diseases and diabetes.

We thrive in and adapt to the ever-changing landscape of biotechnology and pharmaceutical industries.

At SCiAN you will gain invaluable skills in all areas of clinical trial development and have the opportunity to work with innovative technologies and industry leaders.


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


Key Responsibilities

  • 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
  • Performs User Acceptance Testing of databases and documentation of testing
  • Author CRF completion guidelines
  • Updates control CDM documents: DMP, DVP, CCG etc.
  • Performs clinical study data review (non-medical reviews) and generate/resolve queries
  • Code AE, medical history and medications; generate queries
  • Performs SAE reconciliation and generate queries
  • Manage users in EDC databases
  • Verifies database design changes done by less experienced CDAs, as requested by Project Manager
  • Reviews changes to clinical database performed by less experienced CDAs, based on queries, site-generated DCFs and DMP (internal resolutions)
  • Reviews queries and self-evident corrections proposed by less experienced CDAs
  • Reviews queries raised by less experienced CDAs for the coding of AEs, medical history and medications
  • Other duties as assigned


Qualifications

  • 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:

  • You will have the opportunity to play an integral role in helping our clients and the industry shape the future of drug development
  • You will 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.
  • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation.
  • Work with and leverage the best and brightest minds in the industry.
  • We value our employees, and we encourage a culture of collaboration, respect and empowerment.
  • Competitive Compensation.
  • Work / Life Balance.
  • Hybrid schedule.
  • Company Sponsored Training.


If you have a strong technical and academic background, leadership and collaborative skills, and passion for clinical research, we invite you to apply by submitting your cover letter and resume. We are an equal opportunity employer and support diversity in our workplace.

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