Sommario
About the Role
- Lead functional activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
- Co-ordinate activities of Data Managers either internally or externally.
- Make data Mgmt decisions and propose strategies at study or project level.
- Ensure application of consistent data Mgmt processes, influence increased standardization and documentation across assigned project/programs -Comply with company, department and industry standards and processes.
- Provide and implement data Mgmt solutions; ensure knowledge sharing.
- Leads process and training deliverables within multiple platforms, franchises or therapeutic areasDevelops strategies to ensure effective training and knowledge retention.
- Progresses DO towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting).
- Drives towards agreed deliverables, proactively addressing potential issues before they become problematic -Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data Mgmt aspects.
- Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.
- Manages and measures quality -Coordinates exception requests, deviations and corrective/preventative action plansEnsure timely and quality development/ validation of CRFs and edit specifications for assigned studies/programs Responsible for quality control and audit readiness of all assigned data Mgmt deliverables as well as accuracy and reliability of the clinical database.
- Coaches & mentors associates as required -Act as subject matter expert (SME) or, as assigned, lead process improvement/non clinical project initiatives.
- Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects -Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions -Represent Data Mgmt at audits & in Health Authority (HA) meetings for assigned project(s) -Provide Functional/technical Coding leadership for Therapeutic Area/Franchisee having multiple trials or mega trials in the role of Lead Coder ans ensures that Clinical Coding is performed at a consistently high standard.
- Serves as the primary program/therapeutic area lead ensuring timely & quality deliverables by es
- Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Data Mgmt activities and deliverables.
- No critical audit findings due to Data Mgmt -Effectiveness of participation in internal and external networks/initiatives.
- Adherence to Novartis policy and guidelines -Customer / partner/ project feedback and satisfaction -
Work Experience:
- Cross Cultural Experience.
- Project Management.
- Functional Breadth.
- Statistical Programming.
- Modeling & Simulation.
- Biostatistics.
- Compound to the Clinic - Preclinical and Translational Medicine.
- Post Authorization Data Safety.
- Over The Counter Product Development.
- Trial Planning and Feasibility.
- Regulatory Strategy.
- Clinical Trial Set-up, Management & Conduct.
- From Hit to Lead - Lead Discovery & Optimization.
- English.
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