Clinical Data Associate

2 weeks ago

Toronto, Ontario, Canada SCiAN Services Full time
About SCiAN Services

We are a rapidly growing Contract Research Organization with a passion for innovation in the Biotechnology/Pharmaceutical Industry. With over 35 years of experience, we offer services in Pharmacovigilance, Biostatistics, Data Management, and Custom Database Solutions.

Job Title: Clinical Data AssociateJob Summary:

We are seeking an experienced Clinical Data Associate to oversee CDM projects and resources, ensuring 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
  • 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
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
Salary and Benefits:

The estimated salary for this position is around $80,000-$110,000 per year, depending on experience. We also offer competitive benefits, including work/life balance, hybrid schedule, company-sponsored training, and opportunities for professional growth.

We value our employees and encourage a culture of collaboration, respect, and empowerment. If you have a strong technical and academic background, leadership and collaborative skills, and a passion for clinical research, we invite you to apply.

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