ppbLocation: /b Remote, Italy – open to candidates based anywhere in Italy /ppbEmployment Type: /b Full-Time, 12-Month Fixed-Term Contract /ppbHours: /b 40 hours per week /ppbStart Date: /b To be confirmed /ppbClient: /b Leading Global Medical Device Organisation /ph3About the Role: /h3pWe are currently building a pipeline for an exciting opportunity with a leading global medical device organisation for a bClinical Contracts Associate – Italy. /b /ppThis role will support clinical research activities across the EMEA region, with responsibility for the preparation, review, negotiation and execution of clinical trial contracts, budgets and related amendments. /ppWorking with clinical, legal, compliance and other cross‑functional stakeholders, the Clinical Contracts Associate will help ensure agreements are commercially appropriate, aligned with clinical study requirements and compliant with applicable regulations and company policies. /ppThe successful candidate will have strong experience in bclinical contracting within the medical device industry /b and be comfortable working independently in a complex, international and highly matrixed environment. /ppbPlease note: /b This opportunity is currently in the project pipeline and is bpending final client go‑ahead /b. The role will be fully remote for candidates based anywhere in Italy. /ph3Key Responsibilities /h3ulliPrepare, review, negotiate and execute clinical trial contracts, budgets, amendments, work orders, modifications and change orders across the EMEA region. /liliAdapt study site budget templates to meet country‑specific and site‑specific requirements. /liliReview clinical agreements and associated documentation to identify potential corporate, legal and commercial risks. /liliDevelop appropriate approaches to mitigate identified contractual risks in collaboration with relevant stakeholders. /liliNegotiate directly with research sites and other external parties regarding contract terms and budgets. /liliCollaborate closely with Legal, Compliance, Clinical Operations, Finance and other internal stakeholders on contractual language and requirements. /liliSupport negotiations relating to indemnification, intellectual property, confidentiality, compensation and other key contractual provisions. /liliEnsure clinical trial budgets accurately reflect protocol requirements, study procedures and applicable internal policies. /liliReview and approve country‑and‑site‑specific changes to Patient Informed Consent documentation relating to injury, data privacy and compensation.



/liliEnsure clinical contracts and budgets are completed accurately and within agreed timelines. /liliMaintain appropriate documentation and records throughout the contracting process. /liliManage multiple contracts and negotiations simultaneously while maintaining a high level of accuracy and attention to detail. /liliWork independently with minimal supervision while escalating complex issues appropriately. /liliAct as a knowledgeable resource for less experienced colleagues where required. /liliContribute to continuous improvement of clinical contracting processes, templates and best practices. /li /ulh3Required Qualifications Experience /h3ulliBachelor’s degree from an accredited university or college, or equivalent relevant professional experience. /lilibMinimum 4 years of relevant experience in clinical research, clinical operations, clinical contracting, healthcare, pharmaceutical or medical device environments. /b /lilibProven experience working with clinical contracts and budgets within the medical device industry – this is essential. /b /liliStrong understanding of the clinical contracting lifecycle, including preparation, review, negotiation, amendment and execution. /liliExperience negotiating with clinical research sites and/or healthcare institutions. /liliStrong understanding of clinical trial budgets and the ability to align financial terms with study protocols and requirements. /liliExcellent written and verbal English communication skills. /liliStrong Microsoft Word and Excel skills. /liliAbility to analyse complex contractual documentation and identify potential risks. /liliStrong organisational skills with the ability to manage multiple priorities and deadlines. /liliHigh level of attention to detail and accuracy. /liliAbility to handle confidential and sensitive information with discretion. /liliStrong interpersonal and stakeholder management skills. /liliComfortable working independently within a highly matrixed, international organisation. /li /ulh3Preferred Qualifications /h3ulli5+ years of experience in clinical contracting and clinical trial budgeting. /liliExperience supporting clinical studies across multiple EMEA countries. /liliFamiliarity with cardiac,



vascular and/or neuromodulation medical device technologies. /liliUnderstanding of clinical study protocols, including study design, procedures, timelines and trial duration. /liliExperience working with Legal, Compliance, Finance and Clinical Operations teams. /liliExperience working within a global, cross‑divisional or enterprise operating model. /liliPrevious experience supporting clinical research conducted in hospitals, research institutions or medical device companies. /liliKnowledge of applicable clinical research regulations and Good Clinical Practice principles. /li /ulh3The successful candidate will demonstrate: /h3ullibClinical Contracting Expertise: /b Strong practical knowledge of clinical agreements, budgets and amendments. /lilibMedical Device Experience: /b Direct experience within the medical device sector is essential. /lilibNegotiation: /b Confidence negotiating contractual and financial terms with external research sites. /lilibRisk Assessment: /b Ability to identify contractual risks and develop practical mitigation strategies. /lilibStakeholder Management: /b Ability to work effectively with Legal, Compliance, Clinical, Finance and external stakeholders. /lilibOrganisation: /b Excellent ability to manage multiple contracts, priorities and deadlines simultaneously. /lilibCommunication: /b Strong written and verbal communication skills in English. /lilibIndependence: /b Comfortable operating with minimal supervision and taking ownership of assigned activities. /lilibAttention to Detail: /b Highly accurate approach to contract documentation, budgets and regulatory requirements. /lilibConfidentiality: /b Professional handling of commercially and clinically sensitive information. /li /ulh3What We Offer /h3ulliFully remote working from anywhere in Italy. /liliOpportunity to work within a leading global medical device organisation. /liliExposure to international clinical research and contracting activities across the EMEA region. /liliCollaboration with multidisciplinary and geographically diverse teams. /liliOpportunity to contribute to clinical studies involving innovative medical technologies. /li /ulpThis position is currently being developed as part of a bclient project pipeline and is subject to final client approval /b. Further information regarding the confirmed start date and project scope will be provided once client approval has been received. /ppbCandidates must be based in Italy and have the right to work in Italy. /b /p /p #J-18808-Ljbffr

📌 Clinical Contracts Associate (Italia)
🏢 Kelly Science, Engineering, Technology & Telecom
📍 Italia