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Company

ICON Strategic Solutions · 19 hours ago

Specialist, Global Site Agreements

United States

Full-time

Remote

Mid Level

3+ years exp

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Responsibilities

Collaborate with COA developers and copyright holders to secure licensing agreements for the use of COA tools in clinical trials.

Negotiate licensing terms and ensure compliance with all intellectual property rights.

Maintain a comprehensive database of licensing agreements and permissions

Manage the end-to-end process of translating COA tools into multiple languages, ensuring cultural and linguistic accuracy.

Liaise with translation vendors, linguists, and subject matter experts to ensure the quality and timeliness of translations.

Oversee linguistic validation processes, including back-translation and cognitive debriefing, to ensure adherence to industry standards.

Ensure all licensing and translation activities adhere to regulatory guidelines and Good Clinical Practice (GCP) standards.

Maintain accurate and up-to-date documentation for audit purposes.

Provide guidance to internal teams on copyright and licensing best practices.

Serve as the primary point of contact for licensing and translation inquiries.

Provide regular updates to internal and external stakeholders on the status of licensing and translation projects.

Collaborate with cross-functional teams, including legal, procurement, and clinical operations, to align on project requirements.

Identify opportunities to streamline licensing and translation workflows.

Implement best practices and innovative solutions to improve efficiency and cost-effectiveness.

Qualification

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Licensing ManagementClinical Research ExperienceTranslation ManagementCOA Tools KnowledgeIntellectual Property LawsTranslation MethodologiesProject ManagementMicrosoft Office SuiteMultitasking SkillsWorkflow CoordinationCultural Accuracy in Translations

Required

Bachelor’s degree in Life Sciences, Linguistics, Business Administration, or a related field.

3+ years of experience in licensing, translations, or related roles within the clinical research or pharmaceutical industry.

Knowledge of COA tools, intellectual property laws, and translation methodologies.

Proficiency in project management and workflow coordination.

Strong organizational and multitasking skills with attention to detail.

Excellent verbal and written communication skills.

Proficiency in Microsoft Office Suite and familiarity with translation management software.

Preferred

Master’s degree

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others