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Clinical Data Coordinator
Innovaderm Research Inc.. Participate in clinical data management activities for clinical trials undertaken or managed by Indero .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management, ensuring compliance with regulatory requirements and industry guidelines while effectively supporting project teams and external vendors. Proficient in using EDC systems and maintaining accurate data management documentation.
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
Clinical Data ManagementData ReconciliationDiscrepancy ManagementDatabase DesignData Management Plan CreationUser Acceptance TestingData Status ReportingAd-Hoc Study ReportingRegulatory ComplianceStudy Metrics Maintenance
Soft Skills
Highly OrganizedDetail-OrientedEffective CommunicationProblem SolvingInterpersonal Skills
Tools & Technologies
Medidata RaveMedrioComputer Technology
Industry Keywords
Clinical TrialsPharmaceutical IndustryCRO EnvironmentICH GuidelinesHealth Canada RegulationsFDA Regulations
About the role
Key responsibilities & impact- Participate in clinical data management activities for clinical trials undertaken or managed by Indero
- Ensure clinical trial data is collected, managed, and reported clearly, accurately, and securely
- Conduct activities in conformance with regulatory requirements, industry guidelines, Indero SOPs, 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, discrepancy management, study metrics maintenance, and study status monitoring
- 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 the data management plan 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 applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
- Legally authorized to work in India
Benefits
Comp & perks- Flexible work schedule
- Permanent full-time position
- Company benefits package
- Ongoing learning and development
- Attractive advancement opportunities
- Stimulating work environment