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3.0 - 7.0 years
0 Lacs
haryana
On-site
As the EDC Systems Specialist, your primary responsibility will be to design eCRF layouts and databases in alignment with EDC systems. You will be tasked with setting up core configurations in Medidata Rave or other EDC platforms. It is mandatory for you to implement dynamic rules and custom functions using C# as per sponsor requirements. Additionally, you will create, test, and maintain edit checks based on Data Validation Specifications. Your role will involve incorporating internal feedback and SAT feedback from sponsors to enhance the eCRFs and components for protocol amendments and metadata updates. You will perform a second/final peer review of deliverables to ensure accuracy and compliance with the specified requirements. Developing RAVE System Configuration Specifications and conducting Internal Configuration Review Meetings (ICRM) and Sponsor Acceptance Meetings (SAM) will also be part of your responsibilities. You will be expected to handle issues related to QC/UAT/PROD environments and track them to closure efficiently. Supporting CRF annotation, dataset comparison, and Clinical View settings are essential tasks in this role. Furthermore, generating reports per sponsor specifications using JReview, SAS, BOXI, and performing database migration tasks for Post Go-Live studies are crucial aspects of this position. As a mentor, you will play a key role in guiding and supporting new hires, providing them with technical expertise and knowledge. Strong protocol reading and understanding skills are mandatory for this role. This is a full-time position that requires your presence in person at the designated work location.,
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user requirements documents, functional specifications, and testing scripts - Interacting with end-users to create specifications and work with programmers for successful delivery - Offering quantitative analytical support to global program teams and assisting in analyzing reports - Supporting the planning, execution, and close-out of Clinical Programs/Trials - Collating and delivering analytics reports for critical decision-making purposes - Maintaining appropriate documentation and working with internal SMEs and key stakeholders to analyze clinical program/trial operational data - Providing training to end-users on the best use of various data review tools - Programming reports of varying complexity within clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R - Demonstrating good knowledge of Novartis Clinical Data Standards for creating report specifications or outputs - Supporting special projects of limited scope, both clinical and non-clinical - Offering study-level expertise and involvement in CTTs - Leading or supporting special projects across various responsibilities, such as systems issues, processes, user support, and training Your performance will be evaluated based on: - Quality and timeliness of deliverables - Revisions to deliverables due to logic or programming errors - Customer feedback and satisfaction To be successful in this role, you should have: - At least 5-7 years of experience in clinical review, reporting programming, business analytics, or clinical trial setup in the pharmaceutical, CRO, or Life Science industry - Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R) - Familiarity with Data Review and/or Business Intelligence tools (e.g., Spotfire, JReview) - Understanding of clinical data management systems and relational databases applied to clinical trials - Attention to detail, quality, time management, and customer focus - Ability to communicate technical concepts to non-technical users - Strong verbal and written communication skills for global collaboration - Knowledge of Drug Development Process, ICHGCP, CDISC standards, and Health Authority guidelines - Capability to train and supervise new or less experienced associates Novartis offers a supportive community of smart, passionate individuals dedicated to making a difference in patients" lives. If you are ready to contribute to breakthroughs that change lives, join us in creating a brighter future together. For more information about Novartis and to explore career opportunities, visit: https://www.novartis.com/about/strategy/people-and-culture If you are interested in staying connected with Novartis for future career opportunities, sign up for our talent community: https://talentnetwork.novartis.com/network To learn about the benefits and rewards of working at Novartis, read our handbook: https://www.novartis.com/careers/benefits-rewards Novartis is committed to fostering an inclusive work environment and diverse teams that reflect the patients and communities we serve. If you require accommodation due to a disability, please contact [email protected] with your request and contact information, including the job requisition number.,
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
maharashtra
On-site
You will be responsible for supporting all statistical programming, data review reporting, and analytics development aspects of assigned studies or project-level activities. Your role will involve producing and tracking reports for various line functions within Global Drug Development to monitor clinical data continuously. You will provide understandable and actionable reports on clinical data to key stakeholders and facilitate interaction with end-users in creating specifications and performing programming activities for successful delivery. In addition, you will provide quantitative analytical support to global program teams, support the planning, execution, and close-out of Clinical Programs/Trials, and collate and deliver analytics reports for critical decision-making. You will also create, file, and maintain appropriate documentation, work with internal subject matter experts and key stakeholders to provide analysis and interpretation of clinical program/trial operational data, and offer necessary training to end-users on the best and consistent use of various data review tools. Your key responsibilities will include programming reports of various complexity from documented requirements within the clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, and R. It is essential to have a good understanding of Novartis Clinical Data Standards and their implementation for the creation of report specifications or outputs. Your performance will be measured based on the quality and timeliness of deliverables, revisions caused by logic or programming errors, and customer feedback and satisfaction. The minimum requirements for this role include 2-5 years of experience in clinical review and reporting programming, business analytics, and/or clinical trial setup in the pharmaceutical, CRO, or Life Science related industry. You should also have a strong knowledge of programming languages, data review tools, clinical data management systems, attention to detail, time management, customer focus, ability to translate technical concepts for non-technical users, and strong verbal and written communication skills. Moreover, you need to understand Drug Development Process, ICHGCP, CDISC standards, and Health Authority guidelines and regulations. Novartis offers a collaborative and supportive environment where smart and passionate individuals like you can make a difference in patients" lives. If you are ready to contribute to creating a brighter future, consider joining our Novartis Network and explore suitable career opportunities. Additionally, Novartis is committed to providing reasonable accommodation to individuals with disabilities. If you require accommodation during the recruitment process, please contact [email protected] with your request and contact information.,
Posted 1 month ago
6.0 - 11.0 years
8 - 18 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
- UG/PG in Statistics, Mathematics, Life sciences, Engineering or Computer related subjects - Min. 6 yrs Exp in Statistical Programming-TLF,ADAM,SDTM,SAS Macros Developement CALL@WHATSAPP- RUKHSAR-9899875055 SHRUTI- 9911988551 SUHANI-9911988552
Posted 2 months ago
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