Evidence Solutions Lead
AbbVie
Madrid, Spain
hace 17 horas
source : Experteer

About AbbVieAbbVie (NYSE : ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions.

The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas : immunology, oncology, virology and neuroscience.

In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

For more information about AbbVie, please visit us at . Follow abbvie on Twitter, Facebook or LinkedIn. Within the scope ofMedical Operations in Medical Department, Evidence Solutions Lead providesleadership and oversight of activities related to evidence generation at theAffiliate level.

  • Responsible of theperformance management of CRO team and services contracted (CRA / CTA).Provides methodologicaland operational advice and guidance for evidence generation to TA Leads andMedical Director at the local level and oversights evidence generation staff inrelation to clinical operations responsibilities and activities;
  • identifiesinfrastructural improvements and implements action plan to ensure evidencegeneration and business objectives are successfully met;
  • ensures alignment oflocal evidence generation activities with global initiatives. Plans, allocates andmanages resources and budget in alignment with AbbVie s Medical Affairs and Researchgoals, priorities and specific projects timelines.

    In collaboration withMedical Director, Medical Operations Manager, TA Leads and functions involvedin local evidence teams (Market Access Value Proposition Managers and BTLs) oversightsgovernance and activities of local evidence teams by molecule.

    Within the scopeof evidence teams, is responsible for : Local Governance of evidence teams : integration into Brand Teams and functional coordination and tools andtemplates development, update and useCo-leading of evidence generationprojects / studies from a methodological and operational perspectiveTraining of local evidence teams members bothon-boarding and continuous training, identifying needs and coordinating andimplementing training plans in collaboration with training departmentCoordination and development of working andanalytical tools and KPIs’ follow-up.

    Ensure implementingand monitoring local clinical studies within Spain with highest QualityStandards and adherence to local GCPs, ICH Guidelines and AbbVie SOPs.

    Responsible of the coordination, planning, supervision and running of the LocalClinical Studies conducted by the Spanish Medical Department.

    Ensures theoptimum running of these studies in accordance with the scheduled projectgoals, timelines and budget.Oversightsand supports methodologically and operationally TA Leads and Medical Advisorsin the evaluations of externals research proposals and IIS, co-leading projectmanagement and milestones achievement.

    In collaboration withMedical Operations Manager and TA Leads, coordinates vendor assessment andmanagement for evidence solutions.

    Identifies, assessand elevates to Medical Operations Manager and Medical Director, issues thatimpact compliance, quality, timelines, budget, resource allocation and work todevelop a resolution to reduce impact and develop alternative solutions.

    QualificationsBachelor s degree, medical / science / nursing backgroundwith grade equivalent at least to Master of science and above.

    Appropriate life-science orhealthcare-related qualification or experience.Appropriate training and experience inmethodology of evidence generation8 years minimum Clinical Research experience,at least 3 year functioning in a lead capacity withmentoring / supervisory / leadership experienceMinimum of 3 years experience in study managementrole including multicenter trials / studies and, ideally, international study managementexperience and budget responsibility.

    Proven experience in clinical operationsproject management roleDemonstrable knowledge of use of projectmanagement tools.Expertise in project management decisions,making backed ideally by appropriate Diploma, master or Specialty course.

    Must have advanced and thorough knowledgerelated to ICH / GCP Guidelines, local regulations and applicable local lows.Demonstrable personnel management experienceincluding managing teams in a matrix / cross-functional environment.

    Ability to build and lead cross-functionalteams and to focus different expectations to the desired activity.Ability to communicate effectively within a multi-cultural / globaltram environment.

    Ability to anticipate long term executionchallenges while moving with high quality and speed.Excellent communication, networking, tact anddiplomacy, organization and people skills, including situations of conflictresolution, problems solving and crisis management.

    Demonstrated proactive andpositive team player.Fluency in English. Rapidly adaptable to a changing environmentand willingness to assess and implement new ideas and opportunities.

    Sound judgment, strong planning andorganizational skills, and the ability to get things done.TravelNoJob TypeExperiencedScheduleFull-timeJob Level CodeICEqual Employment OpportunityAt 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.

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