Clinical Research Associate II / Senior / Principal – Renal, Transplant, Nephrology
Thermo Fisher Scientific
Google Cloud Platform
Senior Analyst, Site Contracts & Budgets
Parexel
full-time
Posted on:
Origin: • 🇫🇷 France
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
