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
- 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
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