Home
Jobs
Companies
Resume
NOVARTIS logo

Principal Clinical Data Standards Specialist

6 - 7 years

8 - 9 Lacs

Hyderabad

Posted:1 week ago| Platform: Naukri logo

Apply

Skills Required

Automation Change management metadata EDC Analytical Functional testing Clinical trials clinical development business rules clinical data

Work Mode

Work from Office

Job Type

Full Time

Job Description

Summary -Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & 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. About the Role Major accountabilities: Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic. Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate. Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner. Provide coordination between the project resources so that deadlines are met on deliverables. Drive development of appropriate user training. Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization. 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: Timely execution of of projects & data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Minimum Requirements: Work Experience: Functional Breadth. Cross Cultural Experience. Managing Crises. Collaborating across boundaries. Operations Management and Execution. Skills: Automation. Biostatistics. Clinical Trials. Computer Programming. Metadata Management. Statistical Analysis. Languages : English. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

More Jobs at NOVARTIS

Innovative Access Head

Thrissur, Trivandrum, Kozhikode, Kochi

5 - 6 yrs
|

INR 17 - 21 Lacs

Territory Business Executive

Kota, Jodhpur, Bikaner, Jaipur

5 - 10 yrs
|

INR 8 - 8 Lacs

Manager

Hyderabad

8 - 13 yrs
|

INR 20 - 25 Lacs

Associate Global Program Regulatory Manager

Hyderabad

18 - 20 yrs
|

INR 50 - 75 Lacs

Manager, Deployment Services

Hyderabad

6 - 11 yrs
|

INR 9 - 14 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Automation Interview Now
NOVARTIS
NOVARTIS
www.novartis.com

Pharmaceutical Manufacturing

Basel Baselstadt

10001 Employees

433 Jobs

    Key People

  • Vas Narasimhan

    CEO

  • Marie-France Tschudin

    President, Innovative Medicines

RecommendedJobs for You

NOVARTIS logo

Principal Clinical Data Standards Specialist

NOVARTIS

Hyderabad

NOVARTIS logo

Principal Clinical Data Standards Specialist

NOVARTIS

Hyderabad

Novartis India logo

Principal Clinical Data Standards Specialist

Novartis India

Hyderabad, Telangana, India

Novartis India logo

Principal Clinical Data Standards Specialist

Novartis India

Hyderabad, Telangana, India

Experion logo

Senior Data Analyst

Experion

Kochi

PwC India logo

Full Stack Lead Developer with GenAI

PwC India

Gurugram, Bengaluru

PwC India logo

Generative AI Technical Lead Developer

PwC India

Gurugram, Bengaluru

Kidvento logo

Content Developer - Data Science

Kidvento

Mysuru

New Groyp Talentoj logo

Data Engineer

New Groyp Talentoj

Hyderabad, Ahmedabad, Bengaluru

DE Recruitment logo

Data Scientist Jr/Sr ...INDIA/USA

DE Recruitment

Hyderabad, Pune, Bengaluru