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Job Description Summary Provides leadership to CRMAs in a country cluster, sets consistent performance standards, drives efficiency and oversees tactical and strategic implementation of clinical development objectives and priorities.Accelerates GDD and NIBR PoC trials in the assigned country cluster by promoting close collaboration with TMO and Medical Affairs to ensure successful allocation, fast clinical trial start-up, best in class recruitment, early identification of potential delays and development of mitigation plans.Efficiently and effectively deploys resources and training to achieve Novartis' objectives in the area of Clinical Drug Development.Job Description Major Accountabilities Functional Excellence Accountable for CRMAs to deliver high quality clinical/medical program and trial feasibility for GDD and NIBR PoC trials; drives country clinical/medical feasibility process and outcome improvement including identification of new investigators and medical experts.Accountable for coordinating cross-CPO/Cluster initiatives to support recruitment for GDD studies, liaising between the CRMAs and the global team.Leverages innovation in clinical trial planning and execution, including patient engagement as appropriate to deliver recruitment goals.Supports CD&A vision to develop innovative clinical development plans that change the world by sharing early insights from sites, regional/local guidelines, patients and payers in partnership with medical affairs and the local Trial Monitoring Organization.Provides Clinical Development leadership to develop and execute innovative, patient-friendly and competitive clinical trial concept sheets/protocols by supporting nomination of experienced CRMAs to GCTs and other global/regional working groups and ensures high quality feedback.Performs CRMA activities as needed to cover potential CRMA resource gaps and may represent the clinical/medical and scientific interests in internal and external forums to support GDD and NIBR trials.In collaboration with the local Trial Monitoring organization accountable for adherence to safety standards, clinical data quality and regulatory legislation.Ensures Cluster delivery by identifying and developing new sites, builds competitive advantage to establish Novartis as a preferred clinical research partner.Is accountable to implement global clinical standards for CRMAs.May coach the development of local study protocols, implementation and analysis, especially for local studies requested by Has.Guide CRMAs on how to ensure a smooth transition and collaboration with Medical Affairs (e.g. transparency of activities, availability of new data etc.).Stakeholder Management Drives trial site performance and provides superior customer experience for investigators/site study teams, significantly impacting the external visibility and reputation of Novartis.Uses advanced influencing skills to manage collaborations between Cluster/local GDD, Medical Affairs and Patient Access, balancing potentially diverging objectives to achieve superior results. Aligns Cluster with Regional objectives.People Hires CRMAs in the Cluster in collaboration with the Regional CRMA Head, the CSO in the country the CRMA will be hired (or delegate) and the country Trial Monitoring Organization.Accountable to implement global clinical standards for CRMAs including details on Roles and Responsibilities and capabilities.Guides targets/objectives, provides development feedback and evaluates performance. Supports development and implements criteria for CRMA performance assessments.Identifies CRMA talents, and promotes further development including succession planning.Promotes adherence/compliance to SOPs, the global training and onboarding plans within the Cluster.May deputize for Regional Head CRMA.Ideal Background Education: Scientific degree: MD, PhD or PharmD to allow diverse CRMA team (MDs preferable, depending on countries needs and availability).
Languages: Speaks and writes English.Speaks at least local language of one country (if other than English).Experience: Skills: Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex clinical/medical/operational issues.Agility to move fast across different therapeutic areas and indications.Experience: At least 6 years experience in pharmaceutical industry with at least 3 years experience in clinical development or trial monitoring across different indications/Therapeutic areas.Demonstrated leadership skills e.g. in a matrix with the ability to inspire teams and external experts.Sound understanding of the overall clinical development and ICH/GCP.Track record of delivering complex global clinical projects in quality and time.Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial.Applies a detailed understanding of the drug in question to provide medical/clinical context as it relates to disease processes, populations, and standards of care.Ability to assess the feasibility of a clinical trial protocol based on cluster medical practice and sound understanding of the overall clinical development plan.Demonstrating an understanding of regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.Providing medical/clinical expertise to facilitate the safe use of product(s) in clinical trials.Skills Desired: Clinical TrialsData AnalysisData MonitoringDrug DevelopmentDrug Discovery ProcessMedical StrategyPeople Management
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