Clinical Contracts Associate
Altro ·
Location: Si candidi qui sotto dopo aver letto tutti i dettagli e le informazioni di supporto relative a questa opportunità di lavoro. 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