Clinical Contracts Associate

Kelly Science, Engineering, Technology & Telecom; Italia; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Kelly Science, Engineering, Technology & Telecom seeks a Clinical Contracts Associate for Italy, fully remote, to manage clinical trial contracts and budgets across the EMEA region. You will collaborate with legal, compliance and clinical teams to ensure compliant, commercially sound agreements.

The ideal candidate has 4+ years in clinical contracting within medical devices, strong English communication, and the ability to work independently in a matrixed, international environment.

Competenze

• Bachelor’s degree from an accredited university, or equivalent relevant professional experience.
• Minimum 4 years of relevant experience in clinical research, clinical operations, clinical contracting, healthcare, pharmaceutical or medical device environments.
• Proven experience working with clinical contracts and budgets within the medical device industry.
• Strong understanding of the clinical contracting lifecycle, including preparation, review, negotiation, amendment and execution.
• Experience negotiating with clinical research sites and/or healthcare institutions.
• Excellent written and verbal English communication skills.
• Strong Microsoft Word and Excel skills.
• Ability to analyse complex contractual documentation and identify potential risks.
• Strong organisational skills with the ability to manage multiple priorities and deadlines.
• Confidentiality and discretion in handling sensitive information.

Mansioni

• Prepare, review, negotiate and execute clinical trial contracts, budgets, amendments, work orders, modifications and change orders across the EMEA region.
• Adapt study site budget templates to meet country-specific and site-specific requirements.
• Review clinical agreements and associated documentation to identify potential corporate, legal and commercial risks.
• Develop appropriate approaches to mitigate identified contractual risks in collaboration with relevant stakeholders.
• Negotiate directly with research sites and other external parties regarding contract terms and budgets.
• Collaborate closely with Legal, Compliance, Clinical Operations, Finance and other internal stakeholders on contractual language and requirements.
• Support negotiations relating to indemnification, intellectual property, confidentiality, compensation and other key contractual provisions.
• Ensure clinical trial budgets accurately reflect protocol requirements, study procedures and applicable internal policies.
• Review and approve country-and-site-specific changes to Patient Informed Consent documentation relating to injury, data privacy and compensation.
• Ensure clinical contracts and budgets are completed accurately and within agreed timelines.
• Maintain appropriate documentation and records throughout the contracting process.
• Manage multiple contracts and negotiations simultaneously while maintaining a high level of accuracy and attention to detail.
• Work independently with minimal supervision while escalating complex issues appropriately.
• Act as a knowledgeable resource for less experienced colleagues where required.
• Contribute to continuous improvement of clinical contracting processes, templates and best practices.

Formazione

Bachelor's degree

Strumenti

MS Word

MS Excel

Descrizione del lavoro

Location: Remote, Italy – open to candidates based anywhere in Italy

Employment Type: Full-Time, 12-Month Fixed-Term Contract

Hours: 40 hours per week

Start Date: To be confirmed

Client: Leading Global Medical Device Organisation

About the Role:

We are currently building a pipeline for an exciting opportunity with a leading global medical device organisation for a Clinical Contracts Associate – Italy.

This 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.

Working 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.

The successful candidate will have strong experience in clinical contracting within the medical device industry and be comfortable working independently in a complex, international and highly matrixed environment.

Please note: This opportunity is currently in the project pipeline and is pending final client go‑ahead. The role will be fully remote for candidates based anywhere in Italy.

Key Responsibilities

• Prepare, review, negotiate and execute clinical trial contracts, budgets, amendments, work orders, modifications and change orders across the EMEA region.
• Adapt study site budget templates to meet country‑specific and site‑specific requirements.
• Review clinical agreements and associated documentation to identify potential corporate, legal and commercial risks.
• Develop appropriate approaches to mitigate identified contractual risks in collaboration with relevant stakeholders.
• Negotiate directly with research sites and other external parties regarding contract terms and budgets.
• Collaborate closely with Legal, Compliance, Clinical Operations, Finance and other internal stakeholders on contractual language and requirements.
• Support negotiations relating to indemnification, intellectual property, confidentiality, compensation and other key contractual provisions.
• Ensure clinical trial budgets accurately reflect protocol requirements, study procedures and applicable internal policies.
• Review and approve country‑and‑site‑specific changes to Patient Informed Consent documentation relating to injury, data privacy and compensation.
• Ensure clinical contracts and budgets are completed accurately and within agreed timelines.
• Maintain appropriate documentation and records throughout the contracting process.
• Manage multiple contracts and negotiations simultaneously while maintaining a high level of accuracy and attention to detail.
• Work independently with minimal supervision while escalating complex issues appropriately.
• Act as a knowledgeable resource for less experienced colleagues where required.
• Contribute to continuous improvement of clinical contracting processes, templates and best practices.

Required Qualifications & Experience

• Bachelor’s degree from an accredited university or college, or equivalent relevant professional experience.
• Minimum 4 years of relevant experience in clinical research, clinical operations, clinical contracting, healthcare, pharmaceutical or medical device environments.
• Proven experience working with clinical contracts and budgets within the medical device industry – this is essential.
• Strong understanding of the clinical contracting lifecycle, including preparation, review, negotiation, amendment and execution.
• Experience negotiating with clinical research sites and/or healthcare institutions.
• Strong understanding of clinical trial budgets and the ability to align financial terms with study protocols and requirements.
• Excellent written and verbal English communication skills.
• Strong Microsoft Word and Excel skills.
• Ability to analyse complex contractual documentation and identify potential risks.
• Strong organisational skills with the ability to manage multiple priorities and deadlines.
• High level of attention to detail and accuracy.
• Ability to handle confidential and sensitive information with discretion.
• Strong interpersonal and stakeholder management skills.
• Comfortable working independently within a highly matrixed, international organisation.

Preferred Qualifications

• 5+ years of experience in clinical contracting and clinical trial budgeting.
• Experience supporting clinical studies across multiple EMEA countries.
• Familiarity with cardiac, vascular and/or neuromodulation medical device technologies.
• Understanding of clinical study protocols, including study design, procedures, timelines and trial duration.
• Experience working with Legal, Compliance, Finance and Clinical Operations teams.
• Experience working within a global, cross‑divisional or enterprise operating model.
• Previous experience supporting clinical research conducted in hospitals, research institutions or medical device companies.
• Knowledge of applicable clinical research regulations and Good Clinical Practice principles.

The successful candidate will demonstrate:

• Clinical Contracting Expertise: Strong practical knowledge of clinical agreements, budgets and amendments.
• Medical Device Experience: Direct experience within the medical device sector is essential.
• Negotiation: Confidence negotiating contractual and financial terms with external research sites.
• Risk Assessment: Ability to identify contractual risks and develop practical mitigation strategies.
• Stakeholder Management: Ability to work effectively with Legal, Compliance, Clinical, Finance and external stakeholders.
• Organisation: Excellent ability to manage multiple contracts, priorities and deadlines simultaneously.
• Communication: Strong written and verbal communication skills in English.
• Independence: Comfortable operating with minimal supervision and taking ownership of assigned activities.
• Attention to Detail: Highly accurate approach to contract documentation, budgets and regulatory requirements.
• Confidentiality: Professional handling of commercially and clinically sensitive information.

What We Offer

• Fully remote working from anywhere in Italy.
• Opportunity to work within a leading global medical device organisation.
• Exposure to international clinical research and contracting activities across the EMEA region.
• Collaboration with multidisciplinary and geographically diverse teams.
• Opportunity to contribute to clinical studies involving innovative medical technologies.

This position is currently being developed as part of a client project pipeline and is subject to final client approval. Further information regarding the confirmed start date and project scope will be provided once client approval has been received.

Candidates must be based in Italy and have the right to work in Italy.