Site Contracts Associate II

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring a Senior Analyst, Site Contracts & Budgets in Argentina.

The Senior Analyst, Site Contracts & Budgets will be part of the Site Contracts & Budgets team, working to execute the clinical site contracts and budgets process for Sponsor clinical development programs, from contract initiation to completion, maintenance, and subsequent amendments. The Senior Analyst must have a good understanding of functions related to the conduct of global clinical studies. Under the direction of the Director, Clinical Outsourcing & Innovation, the Senior Analyst is responsible for executing the end-to-end site contracts process for assigned agreements and supporting the wider site contracts & budgets team to maintain overall standards, financial terms, and compliance for all site contracts

Essential Functions 

• Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts 

• As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols 

• Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines. 

• Track contract progress, complete required follow-ups and coordinate the timely completion of clinical sites contracts 

• Oversee CRO and Functional Service Provider activities in regards to site CDAs 

• Collaborate and coordinate with cross-functional teams; 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 from initiation through contract execution, and build internal metadata to support accurate 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 all outstanding contracts and budgets 

•  Complete required quality checks of appropriate documents and records for completeness and accuracy and ensure adherence to department guidelines/templates; collate quality issues for reporting to team leads 

• Assist management with process improvement projects 

• Coordinate and arrange meetings, prepare agendas, and meeting planning 

• Submit purchase requisitions, where needed, through SAP systems 

• Support the development and maintenance of guidelines, training programs, policies and procedures related to clinical trial contracts and budget. 

• Support the Director and team in the management of other day-to-day activities related to clinical contracts and budgets as requested 

Required Knowledge, Skills, and Abilities  

• Three to five years or 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 in a dynamic and growing organization 

• 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 

•  Some limited travel may be required