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Global Site Contracts Lead

hace 1 mes

Alcobendas, Madrid, España Parexel A tiempo completo
Main Responsibilities:

Negotiate study-specific generic and country Clinical Site Agreement (CSA) templates with the Sponsor.

Support the Project Lead in negotiating country budgets with the Sponsor.

Provide local Clinical Trial Site (CTS) / Clinical Research Associate (CRA) with required CSA country templates.

Manage CSA activities and liaise with the Project Lead, Global Relationship Officer (GRO) Lead, and the Sponsor to ensure CSA start-up deliverables are met.

Key Accountabilities:

Act as a functional specialist on projects and develop study-specific CSA strategies.

Agree and negotiate study-specific generic and country CSA templates 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.

Store the final approved and complete country template and country budget in the Project Management and Execution Database (PMED).

Communicate CSA strategy, CSA turnaround timelines, CTMS tracking requirements, and budget information/updates with the assigned CTS/CRA.

Provide agreed study and country CSA templates to local CTS/CRA for country-specific adaptation.

Coordinate interaction between the GRO Lead, Project Lead, and Sponsor, including overall timeline management for CSAs.

Coordinate the 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, etc., to ensure the relevant CSA database is up-to-date.

Maintain a comprehensive language tracker.

Early recognition of areas of potential problems and formulate contingency plans.

Define solutions strategy for significant CSA changes requested by the site.

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 GRO 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.

Escalate changes that fall outside the documented fall-back parameters to the Sponsor or to the Clinical Site Agreement Manager as appropriate.