Staff Clinical Database Developer

Year    Gurgaon, Haryana, India

Job Description


Why join Stryker We are proud to be named one the World\'s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific. Know someone at Stryker Be sure to have them submit you as a referrral prior to applying for this position. Learn more about our Stryker is one of the world\'s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Database Developer to join our Neurovascular Division to be based in SGTC, Gurgaon, India. Stryker\'s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization will be working to \'Make Stroke History\'. Stroke is devastating 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: . Who we want Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate. Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. What you will do As a lead Clinical Database Developer to manage and support all related functional tasks and project deliverables from single study assignments to large programs of studies. Manages multiple project timelines and deliverable. Designs, writes, validates, and maintains software to meet specifications. As a technical subject matter expert, supports clinical programming and Data Management staff for Electronic Data Capture (EDC), reporting, and processing tools. Proactively monitors internally and externally hosted applications for performance and/or system errors. Manages external application vendor issues, integrations, and implementations. May have supervisory responsibility and/or oversight for junior clinical programmers within a program. Design the EDC specifications of trial build services for core configuration, eCRFs, data validations (DVS), custom functions and reporting Develop configuration of the EDC trial by utilizing the trial design specifications for eCRFs, DVS, custom functions integrations and reporting Perform EDC User and Site Administration to include site set up and assignment of roles, permissions and eLearning requirements Implement and perform data integrations related activities to ensure data integrations meet project requirements Collaborate with the project team to ensure the EDC configuration is completed on time with high quality Collaborate with the project team to ensure data can be extracted easily from the back-end to support efficient downstream reporting and analysis Provide Quality Control on deliverables developed by other team members or vendors Maintain all required Configuration Specifications and Quality Control documents as required by SOPs and Processes Collaborate with training team as an EDC Subject Matter Expert and perform training as necessary Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams and other stakeholders As SME, is responsible to provide escalation of study specific functional issues, application/vendor issues, testing and validation needs, enhancement requirements, custom functions and/or custom reporting Work on efforts related to EDC systems including UAT and global library/standards development Ensure compliance with Stryker/industry quality standards, regulations, guidelines and procedures Build, maintain and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) in order to facilitate the creation of study level databases to collect clinical trial data. Work with Clinical Data Standards, Data Managers, and other EDC Database Developers to implement new or modified global library objects and to develop appropriate timelines for delivery of the global library objects. Actively participate in and/or lead continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability. Liaise with and review work delivered by external partners (e.g. Functional Service Providers, CROs, technology providers, etc.). Other duties, as assigned. What you need Four-year college degree or higher, STEM preferred (Computer Science or Health related field) and/or equivalent work experience Minimum 7 years in Pharmaceutical/Biotechnology/Medical Device industry or equivalent Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities (SDLC) and CDISC standards (CDASH, SDTM) Excellent verbal and written communication skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills Excellent team player Minimum 5 years\' experience with Medidata Rave platform, including Architect. Certified RAVE Developer highly preferred. Custom Functions programming experience using C# An understanding of database and dictionary structures (e.g. MedDRA, WHODrug). Experience with Database programming is a plus: Oracle, SQL Server Familiarity with other EDC Systems: Oracle InForm, IBM Merge preferred Experience with Business Intelligence Tools: Business Objects, JReview, Cognos, or related preferred About Stryker Stryker is one of the world\'s leading medical technology companies and, together with our customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually. More information is available at

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Job Detail

  • Job Id
    JD3094180
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Gurgaon, Haryana, India
  • Education
    Not mentioned
  • Experience
    Year