Specialist, Site Contracts - Japan- Remote

Worldwide Clinical Trials·Remote(Japan)
Other
Excel

WFA Digital Insight

As demand for clinical trials continues to rise, with a 25% increase in global trials over the past year, the need for skilled contract specialists is at an all-time high. This role at Worldwide Clinical Trials offers a unique opportunity to work at the forefront of clinical research, leveraging Excel skills to drive contract management. With the shift towards decentralized trials, companies are seeking professionals who can navigate complex regulatory landscapes and negotiate contracts with ease. Before applying, candidates should be aware that this role requires a deep understanding of clinical research operations, contract law, and the ability to work in a fast-paced environment.

Job Description

About the Role

The Specialist, Site Contracts role at Worldwide Clinical Trials is a critical position that requires a unique blend of contract management, negotiation, and regulatory compliance skills. As a key member of the Site Contracts department, you will be responsible for preparing, reviewing, and negotiating clinical research site contracts, ensuring compliance with applicable laws and regulations. The successful candidate will have a strong understanding of contract law, clinical research operations, and the ability to work in a fast-paced environment.

The Site Contracts department is a vital part of Worldwide Clinical Trials, responsible for managing all aspects of clinical research site contracts. The team is comprised of experienced professionals who possess a deep understanding of the clinical research industry, contract law, and regulatory compliance. As a Specialist, Site Contracts, you will be working closely with cross-functional teams, including the Legal Department, study teams, and Sponsors, to ensure that all contracts are negotiated and finalized in a timely and efficient manner.

What You Will Do

  • Prepare country-specific contract templates and negotiate contracts with clinical research sites
  • Draft and send Site Agreements and other project-related contracts to sites for negotiation
  • Review study budgets and costs pertaining to contract negotiation
  • Negotiate contract language and budget with each assigned site to finalization/execution
  • Escalate site requests outside of pre-approved parameters to the Site Contracts Lead
  • Ensure that all contracts are fully executed and sent to relevant stakeholders, including sites, eTMF, and the payment team
  • Maintain a tracking tool with live updates for functional activities
  • Prioritize effectively and respond to urgent requests within the internal team or from Sponsors
  • Facilitate contract signatures by Worldwide, when applicable
  • Create a donation agreement, as applicable
  • Review Site Agreements and other contracts for completeness and accuracy

What We Are Looking For

  • 2+ years of experience in contract management, preferably in the clinical research industry
  • Strong understanding of contract law and regulatory compliance
  • Excellent negotiation and communication skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
  • Proficient in Excel and other Microsoft Office applications
  • Experience with clinical research site contracts and study budgets
  • Strong analytical and problem-solving skills
  • Ability to work independently and as part of a cross-functional team

Nice to Have

  • Experience with electronic contract management systems
  • Knowledge of decentralized clinical trials and remote site management
  • Certification in contract management or a related field
  • Experience working with Sponsors and study teams
  • Familiarity with clinical research regulations and guidelines

Benefits and Perks

  • Competitive salary and benefits package
  • Opportunity to work with a global, mid-size CRO
  • Collaborative and dynamic work environment
  • Professional development and growth opportunities
  • Remote work arrangement with flexible working hours
  • Access to cutting-edge technology and tools
  • Recognition and reward programs for outstanding performance

How to Stand Out

  • When applying, be sure to highlight your contract management experience and negotiation skills, as these are key to success in this role.
  • Familiarize yourself with clinical research regulations and guidelines, such as GCP and ICH-GCP, to demonstrate your understanding of the industry.
  • Practice your Excel skills, as this will be a critical tool in managing contracts and study budgets.
  • Prepare examples of your contract negotiation experience, including successful outcomes and challenges overcome.
  • Research Worldwide Clinical Trials and their approach to clinical research, to demonstrate your interest in the company and the role.
  • Be prepared to discuss your experience working in a fast-paced environment and prioritizing multiple tasks, as this is a critical aspect of the Specialist, Site Contracts role.

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