Senior Analyst, Site Contracts and Budgets - FSP

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