Site Contracts Specialist

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

📋 Description

• Develop country-specific contract templates.

• Create and dispatch Site Agreements and site-associated contracts to initiate negotiations.

• Provide planned timelines for execution and updates on negotiation progress.

• Coordinate translation requests and manage translations when necessary.

• Analyze study budgets and expenses related to contract negotiations.

• Negotiate contract terms and budgets with designated sites until finalization and execution.

• Refer site requests that fall outside preapproved guidelines to the Site Contracts Lead and Sponsor.

• Report risks and unresponsive sites to the Site Contracts Lead or internal team.

• Incorporate relevant information or appendices into Site Agreements when equipment is supplied.

• Draft donation agreements when needed.

• Assess Site Agreements and related contracts for thoroughness and accuracy.

• Conclude contracts and budgets with sites.

• Conduct quality reviews prior to the signature phase.

• Provide contracts and budgets to the regulatory team for submission upon request.

• Collaborate with Legal, Data Privacy, study teams, Sponsors, sites, investigators, and other stakeholders.

• Oversee the contract signature process.

• Distribute fully executed agreements to sites, eTMF, payment team, Sponsor, and internal SharePoint.

• Negotiate amendments to Site Agreements and budgets.

• Prepare termination letters and associated documentation.

• Maintain tracking tools with live, real-time, or regular updates.

• Effectively prioritize tasks and respond to urgent requests.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree or equivalent qualification in business administration, finance, science, or a related field.

• 1 to 3 years of experience in the Contract Research Organization, pharmaceutical, or clinical research sector, specifically with investigator/site contracts or a related legal domain.

• Exceptional verbal and written communication skills in English.

• Proficiency in Microsoft Word, Excel, and Outlook.

• Familiarity with the International Council for Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.

• Understanding of local country laws and regulatory standards pertaining to clinical trials.

• Skillful in negotiating contract terms with clinical sites and vendors.

• Capability to identify and resolve contract-related issues and disputes promptly.

• Knowledge of both international and local regulatory frameworks for clinical trials, including FDA, EMA, and ICH-GCP standards.

• Strong analytical, communication, project management, problem-solving, time management, and organizational capabilities.

• Familiarity with contract management software and tools.

• Basic understanding of budgeting and financial concepts related to clinical trial contracts.

• Fundamental knowledge of legal terminology and principles related to contracts.

• Ability to collaborate effectively with cross-functional teams including legal, finance, and clinical operations.

• Capacity to manage a high volume of work and thrive under pressure.

🏝️ Benefits

• Equal employment opportunities.

• A diverse and inclusive work environment.

• Supportive and cooperative teams.

• Accessible leadership.

• Opportunities for employees to succeed and grow professionally.