Clinical Contracts Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7tu88p

pClinical Contracts Associate – Italy /ppbr/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 /ppbProject Status: /b Pipeline opportunity, pending final client approval /ppbClient: /b Leading Global Medical Device Organisation /ppbr/ppAbout the Role: /ppbr/ppWe are currently building a pipeline for an exciting opportunity with a leading global medical device organisation for a bClinical Contracts Associate – Italy. /b /ppbr/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. /ppbr/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. /ppbr/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. /ppbr/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. /ppbr/ppKey Responsibilities /pulliPrepare, 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 /ulpbr/ppRequired Qualifications Experience /pulliBachelor’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 /ulpbr/ppPreferred Qualifications /pulli5+ 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 /ulpbr/ppSkills Competencies /ppbr/ppThe successful candidate will demonstrate: /pullibClinical 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 /ulpbr/ppWhat We Offer /pulliFully remote working from anywhere in Italy. /liliFull-time, 40-hour working week. /lili12-month fixed-term contract. /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 /ulpbr/ppImportant Information: /ppbr/ppThis 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. /ppbr/ppbCandidates must be based in Italy and have the right to work in Italy. /b /p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7tu88p