Job Profile. Site Contract Leader
The candidate will be responsible for 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. Responsibilities include managing CSA activities and liaising with PL, GRO Lead and the Sponsor to ensure that the CSA start-up deliverables are met. Also responsible for the coordination of the local CTS /CRA working on CSAs on a project level for all countries in own region. Provides Work Direction to Project team members as appropriate. Works Closely with all project team member and Legal Department. 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 and 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 company or Client instructions. Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP. Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims). Should be an 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.