Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts
Oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets align with study protocols
Ensure compliance of contracts with Fair Market Value (FMV) principles and guidelines
Track contract progress, complete required follow-ups and coordinate timely completion of clinical site contracts
Oversee CRO and Functional Service Provider activities
Collaborate and coordinate with cross-functional teams including R&D, Legal, Compliance, Procurement and Finance in executing contracts
Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle and build internal metadata for reporting
Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes
Provide accurate progress updates to Clinical Operations teams on outstanding contracts and budgets
Complete required quality checks of documents and records for completeness and accuracy and collate quality issues for reporting
Assist management with process improvement projects and support day-to-day activities
Coordinate and arrange meetings, prepare agendas, and perform meeting planning
Submit purchase requisitions through SAP systems where needed
Support the development and maintenance of guidelines, training programs, policies and procedures related to clinical trial contracts and budget
Requirements
3 – 5 years’ experience in the pharmaceutical or biotechnology industry in clinical site contracts and/or outsourcing management
Proficient with Excel and PowerPoint
Excellent verbal, written and interpersonal communication skills
Willingness to learn international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
Strong interest in learning more about contracts and budgeting in support of Sponsor clinical trials
Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety
Ability to prioritize and manage multiple tasks simultaneously
Benefits
Fully remote home-based position (though limited travel may be required)
Tremendous long-term job security and prospects
Opportunity to work on clinical studies for leading global biotechs and Pharma top 50
Opportunity for professional development and career growth
BPaaS Service Readiness Analyst participating in payroll deployment projects from configuration to go - live. Involves QA validation, collaboration, and ensuring compliance with payroll regulations.
Analista de UAP optimizing production efficiency of manufacturing processes at MANN+HUMMEL. Leading projects for quality improvement and training staff in production routines.
Application Analyst enhancing TUHS applications and supporting system upgrades at Temple Health. Involves addressing defects, analyzing requirements, and educating stakeholders in a hybrid work setting.
Analista de Transportes managing freight costs at Estoca, a tech - driven logistics company. Supporting decision - making through data analysis and interdepartmental collaboration.
Senior Financial Analyst ensuring fiscal compliance for Mollica IT. Responsible for tax calculations, accounting registrations, and financial reports in São Paulo.
Lead Business Analyst focusing on data analytics and business intelligence at BenchSci. Collaborating across teams to define and drive analytical strategy for informed decision - making.
Analista Controladoria I at SOMOS Educação supporting financial reporting and audits. Collaborating with senior analysts and contributing to budgeting and reporting processes.
Engineering analyst managing construction projects and collaborating with stakeholders at Localiza&Co. Involved in prioritizing projects and ensuring technical compliance with project specifications.
Junior Analyst specializing in processes and quality for franchises at Localiza&Co. Engaging in operational excellence through performance monitoring and training.
Senior DHO Analyst driving strategic initiatives in performance, culture, and leadership for the business. Partnering with management to implement effective development programs.