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 clientSenior 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 

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