Within the scope of Medical Operations in Medical Department, Evidence Solutions Manager (ESM) 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 :
Local Governance of evidence teams : integration into Brand Teams and functional coordination and tools and templates development, update and use
Co-leading of evidence generation projects / studies from a methodological and operational perspective
Training of local evidence teams members both on-boarding and continuous training, identifying needs and coordinating and implementing training plans in collaboration with training department
Coordination and development of working and analytical tools and KPIs’ follow-up.
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.
SKILLS REQUIRED :
Be educated in AbbVie products and therapeutic areas
Extensive understand of clinical research management and conduct.
Extensive understand of evidence generation methodology : clinical research methodology and levels of evidence and both regulatory and legal context.
Strong Project Management skills, use of PM tools and savvy use of project management resources.
Organization and planning skills.
Coordination and team player.
Communication and relationships building abilities.
High working level of English.
Knowledgeable in budget creation, keeping and tracking.
Process improvement / oriented mindset.
Bachelor s degree, medical / science / nursing background with grade equivalent at least to Master of science and above.
Appropriate life-science or healthcare-related qualification or experience.
Appropriate training and experience in methodology of evidence generation
8 years minimum Clinical Research experience, at least 3 year functioning in a lead capacity with mentoring / supervisory / leadership experience
Minimum of 3 years experience in study management role including multicenter trials / studies and, ideally, international study management experience and budget responsibility.
Proven experience in clinical operations project management role
Demonstrable knowledge of use of project management tools.
Expertise in project management decisions, making backed ideally by appropriate Diploma, master or Specialty course.
Must have advanced and thorough knowledge related to ICH / GCP Guidelines, local regulations and applicable local lows.
Demonstrable personnel management experience including managing teams in a matrix / cross-functional environment.
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.