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Clinical Data Coordinator
Innovaderm Research Inc.. Participate in clinical data management activities to ensure clinical trial data are collected, managed and reported clearly, accurately and securely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management, including data collection, management, and reporting in compliance with regulatory requirements and industry guidelines. Proficient in using EDC systems and maintaining accurate study documentation while effectively communicating with project teams and stakeholders.
Highest-signal resume keywords
Clinical Data ManagementEDC System ExperienceKnowledge of CDASH/SDTMUnderstanding of Good Clinical PracticesProject Planning and Time Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data ReviewData ReconciliationDiscrepancy ManagementDatabase DesignData Management PlansUser Acceptance TestingStudy Metrics MaintenanceAd-Hoc ReportingCRF MonitoringRegulatory Compliance
Soft Skills
Organizational SkillsEffective CommunicationProblem SolvingInterpersonal SkillsAgility in Fast-Paced Environments
Tools & Technologies
Medidata RaveMedrioComputer Technology
Industry Keywords
Pharmaceutical IndustryCRO EnvironmentICH GuidelinesHealth Canada RegulationsFDA Regulations
About the role
Key responsibilities & impact- Participate in clinical data management activities to ensure clinical trial data are collected, managed and reported clearly, accurately and securely
- Conduct activities in conformance with regulatory requirements, industry guidelines, Indero standard operating procedures, sponsor requirements and timelines
- Provide general data management support to the project team, sponsor and external vendors
- Support the Lead Data Manager with data review, data reconciliation and discrepancy management
- Maintain study metrics and monitor study status, including enrollment and CRFs monitored/approved
- Provide data status reports to the project team as needed
- Generate ad-hoc study reports
- Perform user maintenance
- Assist with user acceptance testing
- Assist with database design
- Assist with creating data management plans and related documentation
- Assist in ensuring data management documentation is complete and up-to-date in the trial master file
Requirements
What you’ll need- B.Sc. or related field
- 1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment is considered an asset
- Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset
- Skilled in use of computer technology, and ability to learn new applications
- A general knowledge of CDASH/SDTM is considered an asset
- Highly organized and detail-oriented with effective project planning and time management skills
- Strong verbal and written communication skills in English; French is an asset
- Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands
- Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment
- Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
- Must be legally authorized to work in Argentina
Benefits
Comp & perks- Flexible work schedule / work schedule
- Home-based position
- Ongoing learning and development
- Attractive advancement opportunities
- Accommodations throughout the recruitment and selection process to applicants with disabilities, upon request