Within the scope of Medical Operations in Medical Department, Evidence Solutions Lead provides leadership and oversight of activities related to evidence generation at the Affiliate level.
Responsible of the performance management of CRO team and services contracted (CRA/CTA).
Provides methodological and operational advice and guidance for evidence generation to TA Leads and Medical Director at the local level and oversights evidence generation staff in relation to clinical operations responsibilities and activities; identifies infrastructural improvements and implements action plan to ensure evidence generation and business objectives are successfully met; ensures alignment of local evidence generation activities with global initiatives.
Plans, allocates and manages resources and budget in alignment with AbbVie´s Medical Affairs and Research goals, priorities and specific projects timelines.
In collaboration with Medical Director, Medical Operations Manager, TA Leads and functions involved in local evidence teams (Market Access Value Proposition Managers and BTLs) oversights governance and activities of local evidence teams by molecule. Within the scope of evidence teams, is responsible for:
Ensure implementing and monitoring local clinical studies within Spain with highest Quality Standards and adherence to local GCPs, ICH Guidelines and AbbVie SOPs. Responsible of the coordination, planning, supervision and running of the Local Clinical Studies conducted by the Spanish Medical Department. Ensures the optimum running of these studies in accordance with the scheduled project goals, timelines and budget.
Oversights and supports methodologically and operationally TA Leads and Medical Advisors in the evaluations of externals research proposals and IIS, co-leading project management and milestones achievement.
In collaboration with Medical Operations Manager and TA Leads, coordinates vendor assessment and management for evidence solutions.
Identifies, assess and elevates to Medical Operations Manager and Medical Director, issues that impact compliance, quality, timelines, budget, resource allocation and work to develop a resolution to reduce impact and develop alternative solutions.