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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 team, 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

  • Negotiate study-specific generic and country CSA templates with sponsors and support the Project Lead in the negotiation of country budgets.
  • Manage CSA activities and liaise with the Project Lead, Global Regulatory Operations Lead, and sponsors to ensure that CSA start-up deliverables are met.
  • Coordinate the local Clinical Trial Site (CTS) / Clinical Research Associate (CRA) working on CSAs on a project level.
  • Act as a functional specialist on projects and develop study-specific CSA strategies.
  • Agree and negotiate study-specific generic and country CSA templates with sponsors.
  • Support the Project Lead in the negotiation of country budgets with sponsors.
  • Gather relevant study information from the Project Lead.
  • Discuss and finalize specific country CSA templates with input from sponsors, the Project Lead, and the Global Regulatory Operations Lead if appropriate.
  • Communicate CSA strategy, CSA turnaround timelines, CTMS tracking requirements, and budget information/updates with assigned CTS/CRA.
  • Provide agreed study and country CSA templates to local CTS/CRA for country-specific adaptation.
  • Coordinate interaction between the Global Regulatory Operations Lead, the Project Lead, and sponsors, including overall timeline management for CSAs.
  • Coordinate overall CSA process with assigned CTS/CRA and status reporting to the Global Regulatory Operations Lead/Project Lead.
  • Provide updates about template amendments, process changes, investigator fees, local requirements, etc., to ensure that relevant CSA databases are up-to-date.
  • Maintain comprehensive language trackers.
  • Early recognition of areas of potential problems and formulate contingency plans.
  • Define solutions strategies for significant CSA changes requested by the site, whereas minor administrative changes are done by local CTS/CRA.
  • Evaluate and identify resourcing needs of SSU staff to be assigned on the project and provide performance feedback as appropriate.
  • Participate in client, investigator, and team meetings.
  • Identify and facilitate CSA training needs of local CTS/CRA.
  • Maintain and assure quality of work generated.
  • Compile CSA status within a project as agreed with the Project Lead and the Global Regulatory Operations Lead.
  • Prioritize effectively and respond to urgent requests within the team or sponsor lead.
  • Provide mentoring and coaching to CTS staff.
  • Resolve negotiation issues that have arisen at the clinical site and escalated from the CTS that cannot be resolved by the CTS after several attempts.
  • Escalate changes that fall outside the documented "fall-back" parameters, if available, to the Sponsor or to the Clinical Site Agreement Manager as appropriate.
  • Provide internal and Sponsor approval to CTS for signature of the fully agreed CSA according to applicable PAREXEL or Client instructions.
  • Maintain a working knowledge of, and ensure compliance with, applicable ICH-GCP Guidelines, local regulatory requirements, and PAREXEL WSOPs and study-specific procedures.
  • Complete routine administrative tasks in a timely manner (e.g., Timesheets, metrics, travel expense claims).

Requirements

  • Experienced CRA, CTS, or a senior person with a legal or business degree or other relevant experience, preferably in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal), or in a comparable function in another CRO or pharmaceutical company.
  • Global Site Contract Lead experience.
  • Excellent computer and internet skills, including excellent knowledge of MS-Office products such as Excel, Word.
  • Possess strong negotiation, diplomacy, team leadership skills, and excellent organizational ability.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to motivate both individuals and a team.
  • Ability to successfully work in a "virtual" team environment.
  • Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks.
  • Shows commitment to and performs consistently high-quality work.
  • Ability to identify and address issues proactively in a timely manner.
  • Ability to take initiative, work independently, and delegate.

Education

  • Degree in business, legal, or life science or other relevant work experience in Contracting, Clinical Operations, or in Legal (Paralegal).

Language Skills

  • Fluent in written and spoken English and local language.