Clinical Contracts Associate

Advanced Clinical; Italia; In loco; EUR 42.000 - 66.000; Tempo pieno

Descrizione del lavoro

Advanced Clinical in Italy is seeking a Clinical Contracts Associate to manage the preparation, negotiation and execution of clinical trial contracts and budgets across EMEA. You will work with research sites and collaborate with legal, compliance and clinical teams to resolve issues and keep studies moving forward.

The role requires at least four years in clinical research, hands-on contract experience, and strong written and spoken English.

Competenze

• Minimum of four years in clinical research, pharmaceuticals, medical devices or a clinical environment.
• Strong hands-on experience with clinical trial contracts and site budget negotiation.
• Ability to work independently, manage deadlines and handle confidential information.
• Excellent written and spoken English; able to negotiate directly with research sites.

Mansioni

• Prepare, review and negotiate clinical site agreements, work orders, amendments and change orders.
• Adapt study budget templates to country and site requirements, reflecting protocol activities and policies.
• Assess contractual risk and propose practical solutions.
• Negotiate terms covering indemnification, IP, confidentiality and compensation.
• Review country and site changes to informed consent wording related to injury, data privacy and compensation.
• Manage workload independently and mentor colleagues as needed.

Conoscenze

Contract negotiation

Clinical budgeting

Independent work

Communication

Formazione

Degree or equivalent experience

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

Contract: Initial 12 months, with potential for rolling 12-month extensions

We are looking for a Clinical Contracts Associate to manage the preparation, negotiation and execution of clinical trial contracts and budgets across EMEA. You will work directly with research sites and collaborate with legal, compliance and clinical teams to resolve contractual issues and keep studies moving forward.

Responsibilities

• Prepare, review and negotiate clinical site agreements, work orders, amendments and change orders.
• Adapt study budget templates to country and site requirements, ensuring budgets reflect protocol activities and applicable policies.
• Assess contractual risk and propose practical solutions.
• Negotiate terms covering indemnification, intellectual property, confidentiality and compensation.
• Review country and site changes to informed consent wording concerning injury, data privacy and compensation.
• Manage your workload independently and provide guidance to less experienced colleagues when needed.

Requirements

• At least four years of relevant experience in clinical research, pharmaceuticals, medical devices or a clinical environment.
• Strong hands-on experience with clinical trial contracts and site budget negotiation.
• Ability to work independently, manage competing deadlines and handle confidential information.
• Strong written and spoken English, with the confidence to negotiate directly with research sites.
• Good working knowledge of Microsoft Word and Excel.
• A degree or equivalent relevant experience.

Experience with cardiac, vascular or neuromodulation studies would be an advantage, as would a strong understanding of clinical study protocols.