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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Clinical Trials Information System (CTIS) submissions and documentation, ensuring quality control and compliance with regulatory standards. Proficient in coordinating resources, managing data entry, and liaising with stakeholders to facilitate effective communication and project timelines.
Highest-signal resume keywords
Clinical Trials Information System (CTIS)Regulatory SubmissionsData EntryQuality Control ReviewsAdvanced English
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 ManagementDocument ManagementSubmission CoordinationRisk MitigationQuality Control
Soft Skills
Independent WorkStakeholder LiaisonProblem Solving
Industry Keywords
Clinical ResearchClinical TerminologyDocumentationProject-Specific Training
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Work with the Clinical Trials Information System (CTIS)
- Provide support for submissions and other documents, including assembly and dispatch
- Coordinate resources for submissions
- Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS
- Liaise with internal and external stakeholders to resolve issues
- Maintain applicable study-level account access for assigned CTIS projects
- Manage and perform data entry and document uploads
- Monitor CTIS and notify applicable stakeholders of activities for action and follow-up
- Create files documenting CTIS submissions, conclusions, decisions, and communications
- Perform quality control reviews according to applicable processes
- Maintain agreed timelines
- Ensure project-specific training is completed on time
Requirements
What you’ll need- Mandatory advanced English (speak, read, write)
- Ideally 1-2 years relevant experience within clinical research or knowledge of clinical terminology and documentation
- Ability to work independently
- Experience with regulatory submissions and CTIS is a differential but not mandatory
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
- Reasonable accommodations during the recruitment process
- Inclusive and accessible workplace