Clinical Data Associate Specialist
2 weeks ago
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
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
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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