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Global Site Contracts Lead

hace 2 meses

Alcobendas, Madrid, España Parexel A tiempo completo
About the Role

Parexel is seeking a highly skilled Global Site Contracts Lead to join our team. As a key member of our Clinical Operations department, you will be responsible for negotiating study-specific generic and country Clinical Site Agreement (CSA) templates with sponsors and supporting the Project Lead in the negotiation of country budgets.

Key Responsibilities
  • Develop and implement study-specific CSA strategies to ensure compliance with regulatory requirements and Parexel's business objectives.
  • Negotiate and agree on study-specific generic and country CSA templates with sponsors, taking into account local regulations and Parexel's standard operating procedures.
  • Support the Project Lead in the negotiation of country budgets with sponsors, ensuring that all necessary information is gathered and presented in a clear and concise manner.
  • Coordinate the development and implementation of CSA start-up deliverables, working closely with the Project Lead, GRO Lead, and sponsors.
  • Provide guidance and support to local Clinical Trial Site (CTS) and Contract Research Associate (CRA) staff on CSA-related matters, ensuring that all necessary templates and information are available and up-to-date.
  • Identify and escalate potential issues or concerns related to CSA negotiations or implementation, working closely with the Project Lead and GRO Lead to resolve any issues that may arise.
  • Develop and maintain comprehensive language trackers to ensure that all CSA-related documentation is accurate and up-to-date.
  • Participate in client, investigator, and team meetings to ensure that all stakeholders are informed and aligned on CSA-related matters.
  • Identify and facilitate CSA training needs for local CTS and CRA staff, ensuring that all necessary training is provided in a timely and effective manner.
  • Maintain and assure the quality of work generated, ensuring that all CSA-related documentation is accurate, complete, and compliant with regulatory requirements.
Requirements
  • Experience as a CRA, CTS, or senior person with a legal or business degree or other relevant experience, preferably in a contracting, clinical operations, legal, or comparable function in a CRO or pharmaceutical company.
  • Global Site Contract Lead experience, with a strong understanding of CSA negotiations and implementation.
  • Excellent computer and internet skills, including proficiency in MS Office products such as Excel and Word.
  • Strong negotiation, diplomacy, team leadership, and organizational skills, with excellent interpersonal, verbal, and written communication skills.
  • Ability to motivate individuals and teams, with a strong commitment to quality and customer satisfaction.
  • Ability to work independently and as part of a virtual team, with a strong focus on collaboration and communication.
  • Ability to identify and address issues proactively, with a strong focus on problem-solving and resolution.
  • Ability to take initiative and delegate tasks effectively, with a strong focus on time management and prioritization.
  • Fluent in written and spoken English and local language, with a strong understanding of local regulations and business practices.