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320 Novartis Jobs

Associate Director- Clinical Data Standards

4-9 years

Mumbai

1 vacancy

Associate Director- Clinical Data Standards

Novartis

posted 16hr ago

Job Description

Summary
Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams.
About the Role
Major accountabilities:
  • Ensuring alignment with the CDS strategy; Responsible for Clinical Data Standard/automation solution planning, definition, development, validation and support
  • Serves as the primary contact for global / TA data standards and/or technologies ensuring timely and quality deliverables.
  • Responsible for driving efficient, high quality and timely implementation of new standards and/or technologies.
  • Ensure efficient governance and approval of global clinical data standards / technologies liaising with governance boards as needed.
  • Lead the technical review and assessment of industry and regulatory standards and technologies supporting regular gap/impact analysis and implementation of action plans where needed.
  • Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.
  • Act as an expert consultant providing Clinical Data Standards input to all relevant areas including electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems.
  • Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.
  • Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent.
Key performance indicators:
  • Timely execution of of projects and data requests;
  • Feedback from project sponsors and key stakeholders
  • Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs
Work Experience:
  • Managing Crises.
  • Functional Breadth.
  • Project Management.
  • Collaborating across boundaries.
  • Representing the organization.
Skills:
  • Automation.
  • Biostatistics.
  • Clinical Trials.
  • Computer Programming.
  • Cross-Functional Teams.
  • Data Analytics.
  • Decision Making Skills.
  • Metadata Management.
  • Statistical Analysis.
Languages :
  • English.

Employment Type: Full Time, Permanent

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What people at Novartis are saying

4.1
 Rating based on 21 Associate Director reviews

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Associate Director salary at Novartis

reported by 141 employees with 13-20 years exp.
₹31 L/yr - ₹75 L/yr
27% more than the average Associate Director Salary in India
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What Novartis employees are saying about work life

based on 1.6k employees
89%
76%
54%
98%
Flexible timing
Monday to Friday
No travel
Day Shift
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Novartis Benefits

Health Insurance
Work From Home
Free Transport
Cafeteria
Soft Skill Training
Gymnasium +6 more
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Novartis Mumbai Office Location

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Mumbai Office
Novartis India Ltd, Sandoz House, Shivsagar Estate, Dr Annie Besant Road, Worli Mumbai
Maharashtra 400018

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