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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Management, including Clinical Document Management and adherence to Global Clinical Research Guidelines. Proficient in managing clinical supplies, budgets, and regulatory submissions while maintaining effective communication and organizational skills.
Highest-signal resume keywords
Clinical Document ManagementClinical Trial ManagementGood Documentation PracticesMicrosoft ExcelICH-GCP Knowledge
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 ResearchClinical Trial DocumentationClinical Trials MonitoringClinical Trials OperationsClinical Trial Support
Soft Skills
Effective CommunicationTime ManagementOrganizational SkillsInterpersonal SkillsConflict Management
Tools & Technologies
Clinical Trial Management Systems (CTMS)MS Office
Industry Keywords
Global Clinical Research GuidelinesRegulatory SubmissionsCulturally Sensitive Working RelationshipsProactive Problem SolvingFinancial Compliance Procedures
About the role
Key responsibilities & impact- Perform comprehensive trial and site administration under the oversight of the line manager
- Prepare, collate, distribute, and archive clinical documents
- Support clinical and non-clinical supply management
- Maintain tracking and reporting tools
- Assist with meeting planned Site Ready dates
- Assist with submission packages to IRB/ERC and Health Authorities
- Collaborate with COM, CRM, CRA, finance, and budgeting representatives
- Track essential documents and report safety reports
- Collate and distribute study tools and documents
- Update CTMS databases and trackers
- Manage labeling requirements and coordinate translation change requests
- Prepare documents and correspondence
- Manage eTMF distribution, archiving, reconciliation, and quality control
- Update manuals and documents, including patient diaries and instructions
- Document destruction of clinical supplies
- Prepare Investigator trial file binders
- Obtain document translations
- Support site evaluation, validation, start-up, and regulatory submissions
- Obtain, track, and update study insurance certificates
- Publish study results where required by local legislation
- Develop, control, update, and close out country and site budgets
- Develop, negotiate, approve, and maintain CTRAs and other contracts
- Track contract negotiations and maintain contract templates with Legal
- Calculate and execute payments to investigators, vendors, and grants
- Ensure financial and compliance procedure adherence
- Monitor and track adherence and disclosures
- Obtain and process FCPA documentation
- Organize meetings and study memos, letters, and protocols
- Support local investigator meetings, including invitations, materials, venue selection, and vendor coordination
Requirements
What you’ll need- Fluent in Local Languages and business proficient in English (verbal and written)
- Good understanding of Global, Country/Regional Clinical Research Guidelines
- Hands-on knowledge of Good Documentation Practices
- Good IT skills, including MS Office and clinical IT applications
- Strong MS Excel skills
- ICH-GCP knowledge appropriate to the role
- Excellent negotiation skills for CTCs in finance area
- Effective time management, organizational, interpersonal, and conflict-management skills
- Effective communication with external customers, sites, and investigators
- Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Ability to work effectively in a matrix multicultural environment
- Ability to establish and maintain culturally sensitive working relationships
- Ability to work independently
- Proactive attitude to solving problems and proposing solutions
- Positive mindset and growth mindset
- Completed job training in office management, administration, finance, or health care, preferred, or Bachelor's Degree
- Required skills: Clinical Document Management, Clinical Research, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Customer-Focused, Microsoft Excel, Microsoft Office
- Preferred skills: Clinical Trial Management Systems (CTMS), Clinical Trials, Communication
- US and Puerto Rico residents only
- No visa sponsorship
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Remote work arrangement
