Emerald Clinical ir globāla klīnisko pētījumu organizācija (CRO), kas dibināta Āzijas un Klusā okeāna reģionā. Aptuveni 25 gadus tā ir atbalstījusi biofarmācijas, medicīnas ierīču un diagnostikas uzņēmumus, nodrošinot pilna cikla klīnisko pētījumu pakalpojumus. Vairāk nekā 800 cilvēku komanda strādā vairāk nekā 40 vietās un vada pētījumus no agrīnās izstrādes līdz reģistrācijai un posmam pēc laišanas tirgū, tostarp klīniskās operācijas, projektu vadību un pētījumu personāla nodrošināšanu. Uzņēmums apvieno zinātnisko kompetenci un operatīvo atbalstu, lai veicinātu zāļu un medicīnas ierīču izstrādi.
Site Contracts Specialist – Clinical Trials (Remote, United States)
Manage clinical trial site agreements and budgets for Emerald Clinical Trials. Support study start-up, site activation, compliance, and sponsor relationships.
Apraksts
- Prepare, review, negotiate, and manage clinical trial agreements, amendments, and related contract documentation
- Develop, negotiate, and manage site budgets within approved sponsor parameters
- Coordinate contract and budget activities with sponsors, investigative sites, legal teams, and internal stakeholders
- Ensure contracts and budgets are completed within study timelines and project milestones
- Maintain contract management systems, trackers, templates, and supporting documentation
- Review contracts for accuracy, completeness, regulatory alignment, sponsor requirements, and company policy compliance
- Track contract status and address negotiation obstacles
- Support site payments and coordinate accurate, timely invoicing
- Assist with country and site start-up, document collection, and study maintenance
- Organize and maintain contract documentation throughout the study lifecycle
- Participate in project meetings and communicate contract and budget progress
- Support quality initiatives, audits, inspections, and process improvement efforts
- Help develop systems, tools, and best practices for contract and budget management
Prasības
- Bachelor’s degree or equivalent qualification in a scientific, healthcare, legal, business, or related discipline
- Prior experience in a CRO, pharmaceutical company, or clinical research setting
- Demonstrated experience negotiating clinical trial site contracts and managing study budgets
- Solid understanding of clinical research, study start-up, and site activation processes
- Working knowledge of ICH-GCP guidelines and applicable regulatory requirements
- Strong negotiation, communication, and stakeholder management abilities
- Ability to assess and interpret contractual, legal, financial, and operational documents
- Exceptional attention to detail, organization, and project coordination skills
- Experience working across multiple countries and cultures is highly desirable
- Proficiency with contract management systems, CTMS platforms, and Microsoft Office applications
- Ability to work independently and collaborate effectively with cross-functional teams
- Proactive, solutions-oriented approach with the ability to balance competing priorities in a fast-paced environment
Priekšrocības
- Competitive salary and benefits package based on skills and experience
- Remote or hybrid work options depending on location and business needs
- Learning opportunities, mentorship, and access to global career pathways
- Wellbeing initiatives that support work-life balance, health, and engagement
- Opportunity to work on international studies across varied therapeutic areas
- Collaborative and supportive workplace culture
- Purpose-driven work supporting clinical trials that improve lives worldwide
- International exposure to leading sponsors and multiple regions