Clinical Data Associate

1 week ago

Toronto, Ontario, Canada SCiAN Services Full time

About SCiAN Services

As a rapidly growing Contract Research Organization, SCiAN Services has established itself as a leader in solving unmet needs in the Biotechnology/Pharmaceutical Industry.

We have over 35 years of experience in delivering innovative services such as Pharmacovigilance, Biostatistics, Data Management, and Custom Database Solutions. Our therapeutic expertise includes immuno-oncology, gene therapy, CNS, infectious disease, autoimmune diseases, and diabetes.

We thrive in an ever-changing landscape and are committed to embracing innovation in everything we do.

Clinical Data Associate Role

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

Key Responsibilities:

  • Develop and design case report forms for efficient data collection
  • Design and develop study databases according to CRF templates, 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 document testing results
  • Author CRF completion guidelines to facilitate accurate data entry
  • Update control CDM documents, including DMP, DVP, CCG, etc.
  • Conduct non-medical reviews of clinical study data and generate/resolve queries
  • Code AE, medical history, and medications; generate queries as needed
  • Perform SAE reconciliation and generate queries to ensure data integrity
  • Manage users in EDC databases for secure access
  • Verify database design changes performed by less experienced CDAs, as requested by the Project Manager
  • Review changes to clinical databases made 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 coding AEs, medical history, and medications
  • Perform other duties assigned by management

Required Skills and Qualifications

  • Bachelor's degree in Life Sciences preferred or equivalent knowledge/experience
  • Minimum 3 years of experience in clinical data management
  • Experience with EDC systems, including Medidata Rave
  • Familiarity with Lotus Notes is an asset
  • Experience in coding AEs, medical history, and concomitant medications
  • Knowledge of SAS is an asset
  • Effective communication and interpersonal skills
  • Ability to work independently with minimal supervision
  • Flexibility in prioritization and adaptability to changing circumstances

Benefits

  • A competitive salary range of $60,000 - $80,000 per year, depending on experience
  • An exciting opportunity to play a key role in shaping the future of drug development
  • Participation in a dynamic and entrepreneurial-minded work environment
  • The chance to collaborate with industry leaders and leverage cutting-edge technologies
  • A culture that values collaboration, respect, and empowerment
  • Hybrid schedule for a better work-life balance
  • Company-sponsored training to enhance your skills and career growth

About You

If you possess a strong technical background, leadership skills, and a passion for clinical research, we invite you to submit your application, including a cover letter and resume. We are an equal opportunity employer and value diversity in our workplace.

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