Contract Specialist – FSP

This is a fully remote position, open to applicants in Italy.

📋 Description

• Assist in the facilitation of site budgets and negotiate contracts.

• Collaborate with both internal and external team members to ensure timely contract execution and adherence to study timelines.

• Aid in the negotiation and management of master clinical trial agreements.

• Engage with designated sites regarding clinical trial agreements, budgets, payment terms, ancillary agreements, and amendments.

• Collaborate with Study Startup, CROs, Clinical Operations teams, and other stakeholders to enhance SB&C metrics and processes.

• Ensure that standards are consistently applied across SB&C processes and projects.

• Utilize industry tools and data sources to offer budget and contract feedback that aligns with parameters and fair market value guidance.

• Identify potential delays, enhance processes, and appropriately escalate issues.

• Monitor actions and negotiations to meet study and site timelines.

• Assist in resolving escalated site activation issues with the internal Study Startup team.

• Provide support for contract review, drafting, negotiation, and lifecycle management of commercial agreements.

• Ensure adherence to corporate policies and regulatory requirements.

⛳️ Requirements

• Bachelor’s degree or an equivalent international qualification.

• A minimum of 2 years of experience in clinical research site contracting and budgeting within a pharmaceutical company, CRO, or relevant industry vendor.

• Familiarity with the pharmaceutical industry, including clinical development and prescription drug distribution.

• Understanding of Clinical Trial Agreements, budgeting, and principles of fair market value.

• Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.

• Ability to interpret data to facilitate data-driven decision-making.

• Understanding of clinical study protocols and schedules of assessments.

• Strong organizational, decision-making, communication, and negotiation abilities.

• Capability to work across various functions, regions, and cultures.

• Ability to effectively represent the company in high-stakes negotiations and constructively resolve conflicts.

• Competence in navigating a complex global ecosystem.

• Capacity to make decisions and take accountability for assigned tasks.

• Willingness to seek diverse stakeholder input and incorporate feedback.

🏝️ Benefits

• Professional development through comprehensive training resources.

• Exposure to various contract types across multiple business units.

• Access to resources to achieve individual career aspirations.

• Reasonable accommodation for individuals with disabilities during the application or interview process.

• Commitment to equal opportunity employment.