Home
Jobs
Companies
Resume
NOVARTIS logo

Associate Director- Clinical Data Standards

4 - 9 years

6 - 11 Lacs

Hyderabad

Posted:2 weeks ago| Platform: Naukri logo

Apply

Skills Required

Automation metadata IVR EDC Project management Clinical trials business rules Subject Matter Expert Clinical data management clinical data

Work Mode

Work from Office

Job Type

Full Time

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. 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

My Connections NOVARTIS

Download Chrome Extension (See your connection in the NOVARTIS )

chrome image
Download 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

Associate Director- Clinical Data Standards

NOVARTIS

Hyderabad

Novartis India logo

Associate Director- Clinical Data Standards

Novartis India

Hyderabad, Telangana, India

Novartis India logo

Associate Director- Clinical Data Standards

Novartis India

Mumbai Metropolitan Region

Vedic Lifesciences logo

Clinical Research Associate/ Sr. CRA

Vedic Lifesciences

Thane, Mumbai (All Areas)

Abiomed logo

Associate Statistical Programmer

Abiomed

Mumbai, Bengaluru

Bristol Myers Squibb logo

Associate Manager, Clinical Data Management

Bristol Myers Squibb

Hyderabad

Randstad logo

JD For Clinical Study design_MBBS_Hyderabad

Randstad

Hyderabad

Parexel logo

Drug Safety Specialist

Parexel

Hyderabad

Accenture logo

Clinical Data Svs Associate

Accenture

Bengaluru

Accenture logo

Clinical Data Svs Specialist

Accenture

Bengaluru