Site Contracts Manager

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

• Supervise the negotiation of clinical study agreements for designated trials.

• Serve as a subject matter expert for sponsors and stakeholders in the respective countries.

• Develop strategies for executing Clinical Site Agreements that align with study initiation plans and client expectations.

• Draft Clinical Site Agreement templates, payment conditions, country budgets, fallback options, and negotiation guidelines.

• Lead negotiations at the study level for CSAs and ensure finalization and execution within specified timelines.

• Negotiate directly with clinical sites within the assigned countries.

• Escalate requests that exceed contractual and budgetary parameters to sponsors or internal decision-makers.

• Provide advice to stakeholders on resolving issues and seek internal support when necessary.

• Create and update document status reports and maintain department tools, systems, and team communications.

• Ensure proper documentation is preserved throughout the contracting process.

• Coordinate status updates with project teams and sponsors.

• Manage discussions regarding fair market value for investigator budgets and payment terms.

• Oversee study team and sponsor expectations concerning the progress of global CSA negotiations.

• Participate in regular study meetings and calls.

• Build strong relationships with sponsors to facilitate smooth negotiations and encourage repeat business.

• Collaborate with legal, finance, and clinical operations departments on legal and budgetary matters.

• Be responsible for the delivery of Site Contracts on assigned projects and initiatives.

• Act as the local subject matter expert in the country of residence or assignment.

• Perform additional duties as assigned by the Line Manager.

⛳️ Requirements

• Bachelor's degree in law, business, life sciences, or a health-related field, or an equivalent combination of education and experience.

• Extensive operational experience with Contract Research Organizations (CROs).

• Proven success in Site Contracts Management at local, regional, international, or global levels.

• Comprehensive understanding of relevant regulations, drug development processes, and clinical project management protocols.

• Familiarity with country-specific Site Contracts requirements in one or more countries, particularly the candidate's country of residence.

• Capacity to work across various geographic regions.

• Ability to mentor and guide less experienced personnel.

• Strong skills in presentation, documentation, and interpersonal communication.

• Proficient in MS Office applications, including Word, Excel, PowerPoint, Outlook, and Internet use.

• Capability to manage multiple tasks and adhere to deadlines in a fast-paced environment.

• Keen attention to detail.

• Strong oral and written communication abilities.

• Ability to work independently.

• Strong leadership capabilities.

• Significant local contracting experience.

• Proficiency in English and fluency in the local language(s) is required.

• Knowledge of Bulgarian, Czech, Hungarian, and Serbian is preferred.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Collaborative environment with an international team.

• Opportunities for career advancement.

• Early ownership and professional growth through mentoring and coaching.

• Chance to contribute to meaningful work that provides safe and effective pharmaceutical treatments to patients.

• Supportive culture.

• Collaboration with experts in clinical research, pharmacovigilance, and quality consulting.