Manager Clinical Practice Jobs in Dalkeith
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Search results - Manager Clinical Practice Jobs in Dalkeith
Novartis-Dalkeith
Clinical Practice, clinical trial design, statistics, and regulatory/clinical development processes
• People management experience preferred, especially at the global level (this may include management in a matrix environment)
Novartis is committed...
Novartis-Dalkeith
in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates
• Oversee/conduct medical and scientific review of trial data with Clinical Scientific Expert(s). May be the Program Manager of other...
Novartis-Dalkeith
to innovate in clinical development study designs, provide relevant evidence to decision-makers and to interpret, discuss and present clinical trial or section program level data
• Detailed knowledge of Good Clinical Practice, clinical trial design, statistics...
Novartis-Dalkeith
Good Clinical Practice (GCP) guidance to day-to-day questions arising from Clinical trials deliverables.
• Collaborate with Country Development QA and External Service Providers (ESP) QA to drive initiatives relevant to internal monitoring...
Novartis-Dalkeith
Heads the ISRC Office and is the line function manager for the Director Protocol & Clinical Program Excellence and ISRC Leads in charge of managing ISRC activities. This includes organization of priority topics, key outcomes and actions and regulatory...
Novartis-Dalkeith
of +/- 5%.
• Cost efficient developed and managed clinical trial forecast / work package with adherence to Novartis business policies. Repeatable and scalable processes / methodologies for trial forecasting management.
• Accuracy of scope tracking to CTTs...
Novartis-Dalkeith
management, coordination and oversight of CSR appendices for assigned studies to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices and Novartis SOPs.
• Support implementation of the submission document readiness...
Novartis-Dalkeith
aspects of budget management for assigned CTTs, with support from Budget Practice Area DU SME, if required:
• Deliver status updates, realistic forecasts, and consolidated timely reports (monthly, quarterly, lifetime) for input into OEP and financial...
Novartis-Dalkeith
and country representatives. Identify potential timeline, quality, or resource issues. Negotiate and implement solutions or escalate to CDO management when necessary for assistance.
• Review and maintain the Clinical Disclosure Office PLTS book of work in...
Novartis-Dalkeith
of pharmacometrics tasks on assigned projects within (early/full) clinical development. Together with the leadership, s/he is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development...
Novartis-Dalkeith
years working experience and excellent knowledge of the clinical operation processes and vendor management
• Excellent knowledge of Good Practice (GxP) and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use...
Novartis-Dalkeith
Experience:
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple...
Novartis-Dalkeith
per agreed timelines and in compliance with worldwide HA requirements, internal working practices and guidelines.
• Act in a global capacity, and partner with various cross-functional stakeholders (e.g., Regulatory Affair Managers, Regulatory CMC...
Novartis-Dalkeith
based Quality Management (RBQM) practice at trial level, oversee the implementation, and continuous improvement. The Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across...
Novartis-Dalkeith
ensuring deadlines are met.
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP).
• Ability to engage in strategic discussions with stakeholders on initiatives that have the potential to boost...
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