Senior Analyst, Site Contracts and Budgets - FSP

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.

Key Accountabilities: 
Oversight of activities

• 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 

• 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 
• 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 
• 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 

Collaborative relationships

• Collaborate and coordinate with cross-functional teams; R&D, Legal, Compliance, Procurement and Finance in executing contracts 

Compliance with Parexel standards 

• Complies with required training curriculum  

• Completes timesheets accurately as required  

• Submits expense reports as required  

• Updates CV as required  

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements  

Skills: 

• Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization 

• Proficient with Excel and PowerPoint 

• Strong interest in learning more about contracts and budgeting in support of Sponsor clinical trials 

• Ability to prioritize and manage multiple tasks simultaneously 

• Some limited travel may be required 

Knowledge and Experience:  

• Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety 

• Willingness to learn international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues 

• This position can be staffed also at Senior level based on years of experience in the pharmaceutical or biotechnology industry in clinical site contracts and/or outsourcing management 
• Analyst, Site Contracts & Budgets level position require 1-3 years of relevant experience as assessed by the client 
• Senior Analyst, Site Contracts & Budgets level position require 3-5 years of relevant experience as assessed by the client 

Education: 

• Educated to degree level or equivalent