-Responsible and accountable for managing all Data Mgmt/Coding / CDD/DAP aspects of several studies, a medium to large sized project or project level activities at a consistently high standard. The position is a key collaborator and strategic partner with stakeholders ensuring that pharmaceutical drug development plans in Novartis Global Drug Developnment are executed efficiently with timely and high quality deliverables. Conceptualize and implement, in a scalable way, appropriate training delivery models and platforms for end-to-end deliverables. Follows and oversees -Good Clinical Practices (GCP), data-handling procedures & guidelines. Ensure consistency across assigned program to aid efficiencies for submissionsParticipates in the review of clinical research protocols, reports and statistical analysis plans. Leads quality deliverables across platforms. Develops simple and reproducible strategies to ensure quality deliverables,
About the Role
Major accountabilities:
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.
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 -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
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
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