Site Contracts Associate

hace 3 semanas

Madrid, España Parexel International A tiempo completo

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for a German speaking Site Contract Associate based in the EMEA region.

The main responsibility of the Site Contract Lead is the negotiation of study specific generic and country Clinical Site Agreement (CSA) templates with the Sponsor and support the PL in the negotiation of country budgets with the Sponsor as well as providing the local CTS/CRA with required CSA country templates.

Further, the responsibilities include managing CSA activities and liaising with PL, GRO Lead and the Sponsor to ensure that the CSA start-up deliverables are met. The Site Contract Associate is responsible for the coordination of the local CTS /CRA working on CSAs on a project level.

Key Accountabilities:

  • Act as functional Specialist on projects and develop study specific CSA strategy.
  • Agree and negotiate study specific generic and country CSA templates with the Sponsor.
  • Support the PL in the negotiation of country budgets with the Sponsor.
  • Gather relevant study information from PL.
  • Discuss and finalize specific country CSA templates with input from Sponsor, PL and GRO Lead if appropriate.
  • Upon sponsor approval of the country specific template, store the final approved and complete country template and country budget PMED.
  • 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, PL and Sponsor including overall timeline management for CSAs.
  • Coordinate overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/PL.
  • Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is up-to-date.
  • Maintain comprehensive language tracker.
  • 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.
  • Compile CSA status within a project as agreed with PL 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.
  • 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 German languages are essential.

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