Director Clinical Data Standards

7 days ago

India Glow Beauty On Demand Full time US$ 90,000 - US$ 1,20,000 per year
Summary Supports Head CDS in setting the standards and automation strategy across Novartis. Manage a global team(s) responsible for executing data standards / automation objectives across DO. Responsible for ensuring quality, scalable, reusable, (CDISC and regulatory) compliant data standards and technologies are transparently deployed across GDO in close collaboration with external industry peers and internal stakeholders delivering stellar customer focus. Responsible for planning and overseeing KPIs/metrics, frameworks,
policies, business rules and processes for development, maintenance, deployment. Responsible to ensure Novartis fulfills a ROI across the standards and automation landscape About the Role

Manage a global team(s) of Clinical Data Standards Specialists providing

operational, technical and strategic management and development of teams .

  • Accountable for all aspects of Clinical Data Standards delivery within assigned

discipline including the strategy and planning to ensure the sucessful development

and maintenance of end-to-end s data and reporting standards in one or more

disciplines of data acquisition and tabulation, analysis and reporting and/or

regulatory data submission across multiple disease/therapeutic areas and drug

development phases .

  • In collaboration with stakeholder and partner functions across and outside of GDO,

accountable for driving standards implementation across the organization and

defines and monitors KPIs/metrics, strategies, frameworks, policies, business

rules and processes for development, maintenance, deployment and adoption with

a strong focus on scientific and regulatory needs.

  • 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.

  • Act as an expert consultant /SME 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.

  • Support the development and maintenance of a high performing, industry

recognized Data Operations organization:

  • May also represent at internal and external decision boards and deputise for Head

CDS as required.

Minimum Requirements:

Work Experience:

  • People Challenges.
  • Functional Breadth.
  • Geographic Scope.
  • People Leadership.
  • Project Management.
  • Collaborating across boundaries.
  • Representing the organization.

Skills:

  • Automation.
  • Biostatistics.
  • Clinical Trials.
  • Computer Programming.
  • Cross-Functional Teams.
  • Data Analytics.
  • Data Strategy.
  • Decision Making Skills.
  • Global Project Management.
  • Metadata Management.
  • Statistical Analysis.

Languages :English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:


Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.


Job Id: /OptdV0bRFmBvN8iWt5c92JO7c3glLtt3LHLYWswWWdmHsbpKVfiIvWUJHxyHjixrCsZAQ2p2DWuWPLDM0OR3J/G7JU4jlKimWYN efjDIOyABezoENjpDzF4ZbL3PogA2ZsXIrSa6 4xG41FujmQ77mijD6EWwecxl7X29vfs06aJq9

  • Clinical Standard and Bio Stats

    7 days ago

    India Tata Consultancy Services Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Job Title: Clinical Standard and Bio StatsJob Location: Pan India (Preferrable: Delhi or Mumbai)Exp Range: Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated...

  • Director, Biometrics

    1 week ago

    India inVentiv Health Clinical SRE, LLC Full time

    Job DescriptionDescriptionDirector, BiometricsSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Every day we perform better because of how we work together, as one...

  • Clinical Operations Director

    1 day ago

    India beBeeOperations Full time ₹ 12,00,000 - ₹ 15,00,000

    Job Description:We are seeking an experienced Clinical Operations Director to lead the development of a process framework for integrating recurring milestone functionality into our TMF Oversight process. This role requires strong analytical and design skills, with the ability to investigate current processes and identify opportunities for optimization.Key...

  • Sr Director, Financial Planning

    7 days ago

    India Endpoint Clinical Full time US$ 1,25,000 - US$ 1,75,000 per year

    About Us: Endpoint is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE platform, have proven to...

  • Clinical Data Specialist

    6 days ago

    India beBeeData Full time ₹ 15,00,000 - ₹ 28,00,000

    Job DescriptionAs a Clinical Data Configurator, you will be responsible for creating and reviewing data specifications as per industry standards. This involves developing and validating analysis datasets, tables, listings, and figures for both safety and efficacy parameters.You will need to understand and comply with ICH-GCP guidelines, core operating...

  • Clinical Data Programmer Ii

    6 days ago

    India Novotech Full time

    **Brief Position Description**: The core responsibility for this position is as a member of the Data Management department at Novotech. The (Senior) Clinical Data Programmer will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). **Minimum Qualifications &...

  • Clinical Data Specialist

    2 days ago

    India beBeeDataSpecialist Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Title: Clinical Data SpecialistKey Responsibilities:Develop and maintain data mappings and listingsCreate visualizations to represent complex data insightsParticipate in reviewing clinical data to ensure accuracy and qualityAutomate tasks and optimize data extraction processesCollaborate with internal/external stakeholders and data engineers to achieve...

  • Clinical Data Scientist

    1 week ago

    India beBeeProgrammer Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Senior Statistical ProgrammerSponsor-dedicated:You will be at the heart of our client's innovation, working fully embedded within one of our global pharmaceutical clients. This company is driving the next generation of patient treatment, empowering individuals with autonomy and ownership.Position Overview:This role involves leveraging advanced SAS...

  • Clinical Data Coder

    4 days ago

    India SureEvents Full time

    **Job Code**:SE / MDC / 00615**Job Location**:Multiple Cities / Hybrid / Remote**Experience**:3 - 5 yrs**Skills Required**: - Bachelor’s degree or equivalent, preferably in Health Sciences. - 3 years’ relevant experience in Clinical Data Coding. - In‐depth knowledge of industry standard coding (MedDRA, WHO Drug) - Experience working on clinical...

  • Clinical Data Programmer Ii

    4 days ago

    India Novotech Full time

    **Brief Position Description**: The core responsibility for this position is as a member of the Data Management department at Novotech. The Clinical Data Programmer-II (CDP-II) will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). **Minimum Qualifications &...