09 set
|
Kelly Science, Engineering, Technology & Telecom
|
Milano
09 set
Kelly Science, Engineering, Technology & Telecom
Milano
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
📌 Clinical Contracts Associate (Milano)
🏢 Kelly Science, Engineering, Technology & Telecom
📍 Milano