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Clinical Data Coordinator
Innovaderm Research Inc.. Provide general data management support to the project team, sponsor and external vendors .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management, including data reconciliation, discrepancy management, and the use of EDC systems. Proficient in maintaining study metrics and documentation while ensuring compliance with Good Clinical Practices and relevant regulations.
Highest-signal resume keywords
Clinical Data ManagementEDC System ExperienceCDASH/SDTM KnowledgeProject PlanningRegulatory Compliance
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 ReconciliationData ReviewDatabase DesignUser Acceptance TestingStudy Metrics Maintenance
Soft Skills
Detail-OrientedEffective CommunicationProblem SolvingOrganizational SkillsTime Management
Tools & Technologies
Medidata RaveMedrio
Industry Keywords
Good Clinical PracticesICH GuidelinesHealth Canada RegulationsFDA RegulationsPharmaceutical Industry
About the role
Key responsibilities & impact- 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 the data management plan and related clinical data management documentation
- Assist in ensuring data management documentation is complete and current 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
- 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 and prioritize multiple competing demands
- Excellent interpersonal, communication, problem solving and organizational skills
- Ability to work independently and in a team environment
- Understanding of the drug development process and applicable regulations, including Good Clinical Practices, ICH Guidelines, Health Canada and FDA regulations/guidelines
- Must be legally able to work in the Philippines
- Attendance at some meetings outside regular business hours, primarily in the evening, is required
Benefits
Comp & perks- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
- Attractive advancement opportunities
- Home-based work location