Associate Director, Functional Service Partnership, Site Contracts

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

📋 Description

• Act as the primary operational expert for clinical contracts and study budgets.

• Oversee the complete budget process from Clinical Study Protocol (CSP) formulation through study initiation, maintenance, closure, and archiving.

• Ensure the application of country-specific Fair Market Value (FMV) at both study and country levels, while managing master study and country budgets.

• Facilitate the prompt distribution of sanctioned country budgets to Site Management and Monitoring/country teams.

• Lead regular and ad hoc evaluations of Clinical Study Agreements (CSAs) and budgets that arise from protocol modifications.

• Maintain a thorough, audit-ready collection of signed CSAs and pertinent documentation.

• Collaborate with Study Management, Site Management & Monitoring, Legal, Procurement, and Finance to achieve project scope, quality, budget, and timelines.

• Develop and enhance standards, templates, guidance, and tools for budgets and CSAs.

⛳️ Requirements

• Bachelor's degree or equivalent qualification.

• Minimum of 5 years of pertinent clinical experience within the pharmaceutical industry, including over 2 years of oversight/project management experience in site budgets and contracts.

• In-depth knowledge of clinical research regulatory standards.

• Strong comprehension of ICH/GCP and study management workflows, encompassing contract and budget management.

• Excellent leadership and cross-functional collaboration capabilities, with a proven ability to influence without direct authority.

• Demonstrated oversight/project management proficiency, including planning, risk management, and timeline and budget supervision.

• Competence with standard project tools and IT systems.

• Exceptional communication, stakeholder management, and relationship-building abilities.

• Proficient in verbal and written English.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Opportunities for professional development.