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Clinical Data Manager
Innovaderm Research Inc.. Provide general data management support to project teams, sponsors, 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 eCRF development, database programming, and compliance with Good Clinical Practices and ICH Guidelines. Proficient in managing data transfer agreements and training site users on EDC systems.
Highest-signal resume keywords
Clinical Data ManagementEDC Systems ProgrammingGood Clinical PracticesCDISC SDTM/CDASH StandardsData Transfer Agreements
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ECRF DevelopmentDatabase ProgrammingData Review and CleaningData Management PlansMedical CodingData Listings GenerationDatabase User ManagementData ReconciliationData Management SOPsClinical Database Validation
Soft Skills
Project PlanningTime ManagementVerbal CommunicationWritten CommunicationProblem Solving
Tools & Technologies
Clinical DatabasesEDC SystemsEPROIWRSTMF
Industry Keywords
Clinical ResearchBiotechnologyPharmaceuticalContract Research OrganizationHealth Canada RegulationsFDA RegulationsMedDRAWHODrugDrug Development ProcessICH Guidelines
About the role
Key responsibilities & impact- Provide general data management support to project teams, sponsors, and external vendors
- Develop eCRF specifications, including data capture screens and edit check specifications
- Program, maintain, validate, and test clinical databases and EDC systems
- Develop eCRF completion guidelines and training materials
- Train site users and monitors on clinical databases
- Develop data transfer agreements and specifications with external-data vendors
- Reconcile external data with EDC data and sponsor safety databases when needed
- Support development of external clinical data systems such as ePRO and IWRS and document/test data transfers
- Develop data management plans and related documentation
- Perform ongoing data review and cleaning through database lock/close
- Code medical terms in clinical databases as required
- Generate data listings and reports for data review and database close/lock
- Monitor study status and provide data status reports
- Maintain complete and current data management documentation in the TMF
- Activate/deactivate database users and maintain request records
- Respond to users needing EDC system assistance
- Archive clinical databases and related documents
- Participate in writing and updating data management SOPs
- Mentor and train a Clinical Data Coordinator
- Oversee outsourced vendors to ensure timelines, deliverables, sponsor requirements, protocol requirements, work orders, and SOPs are met
Requirements
What you’ll need- B.Sc. or in a related field of study
- M.Sc. or in a related field of study is an asset
- Between 5 to 10 years of clinical data management experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (CRO) industry
- Understanding of the drug development process and applicable regulations, including Good Clinical Practices and ICH Guidelines
- Extensive experience working with EDC systems and/or database structures, including demonstrated skills in database programming
- Good understanding of CDISC SDTM/CDASH standards
- Highly organized and detail-oriented with effective project planning and time management skills
- Strong verbal and written communication skills in English
- Excellent problem solving abilities
- Ability to work in a fast-paced environment and prioritize multiple competing demands
- Knowledge of MedDRA and WHODrug dictionaries
- Good knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines
- Must be legally authorized to work in the Philippines
Benefits
Comp & perks- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
- Attractive advancement opportunities
- Home-based work location