Site Contract Associate

3 giorni fa

Roma, Lazio, Italia Parexel A tempo pieno

Parexel is a leading biopharmaceutical services company that improves the world's health by transforming scientific discoveries into new treatments.

We are currently seeking a highly skilled Site Contract Associate to join our team in Italy.

The successful candidate will be responsible for negotiating study-specific generic and country Clinical Site Agreement (CSA) templates with the Sponsor and supporting the Project Lead in the negotiation of country budgets with the Sponsor.

Key responsibilities include managing CSA activities, liaising with the Project Lead, GRO Lead, and Sponsor to ensure CSA start-up deliverables are met, and coordinating the local CTS/CRA working on CSAs on a project level.

Key Accountabilities:

  • Agree and negotiate study-specific generic and country CSA templates with the Sponsor and support the Project Lead in the negotiation of country budgets with the Sponsor.
  • Gather relevant study information from the Project Lead and discuss and finalize specific country CSA templates with input from the Sponsor, Project Lead, and GRO Lead if appropriate.
  • Communicate CSA strategy, CSA turnaround timelines, CTMS tracking requirements, and budget information/updates with the assigned CTS/CRAs.
  • Provide agreed study and country CSA templates to local CTS/CRA for country-specific adaptation.
  • Coordinate interaction between GRO Lead, Project Lead, and Sponsor, including overall timeline management for CSAs.
  • Coordinate overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/Project Lead.
  • Provide updates about template amendments, process changes, investigator fees, local requirements, and ensure the relevant CSA database is up-to-date.
  • Maintain comprehensive language tracker and early recognition of areas of potential problems and formulate contingency plans.
  • Define solutions strategy of significant CSA changes requested by the site, whereas minor administrative changes to be 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, and compile CSA status within a project as agreed with Project Lead and GRO Lead.
  • Prioritize effectively and respond to urgent requests within 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 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.
  • 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.
  • Fluent in written and spoken English and Italian.

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