Contract Specialist

hace 3 semanas


Zaragoza, España Ora A tiempo completo

.POSITION TITLE: Contract Specialist DEPARTMENT: Ora Europe LOCATION: Remote in UK, Spain, Italy or Poland Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor ______________________________________________________________________________ At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America. The Role: The Contract Specialist plays a pivotal role in overseeing the negotiation and preparation of contracts and related documents for participation in industry-sponsored clinical trials. This role involves producing site-specific contracts from country clinical trial agreement (CTA) templates, negotiating budget and contract terms with sites and sponsors. Additionally, the role entails serving as a liaison between Clinical Operations, Project Management, Legal, and external stakeholders to facilitate efficient contract execution and compliance. What You'll Do: Produce site-specific contracts from country CTA templates, review and own site-specific contracts, and submit proposed CTAs for site review. Build country-specific CTA templates, liaising with Legal, Clinical Operation, Regulatory and other relevant stakeholders. Perform quality control and arrange execution of CTAs, ensuring completeness and accuracy of contracts and documenting corrections as needed. Build and own timelines for execution of CTAs for sites at study level in collaboration with Project Management, Clinical Operations and Regulatory. Develop, own and maintain metrics for CTAs execution at the country and site level. Act as a liaison between the CRO, clinical trial sites, sponsors, and other stakeholders, facilitating effective communication to address issues and ensure smooth contract execution. Maintain accurate records of contract-related activities, track contract status, updates, and amendments using contract management systems. Contribute to the development and implementation of best practices for site contract management, streamline processes, improve efficiency, and enhance communication protocols. In partnership with Legal, serve as a clinical trial contract process expert, offering expertise on the regulatory and process intricacies concerning clinical trial contracting within the region



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