3 Rave Medidata Jobs

Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your Role Support the implementation and maintenance of data standards (including CRF, External Data, and SDTM) to ensure consistency across studies. Contribute to the creation of study-specific CRF (Case Report Form) metadata and SDTM (Study Data Tabulation Model) metadata Provide oversight for SDTM packages in outsourced studies, ensuring regulatory compliance, submission readiness, and adherence to standards (CDISC, FDA, EMA, etc.). Support eDC (electronic Data Capture) study set-up activities, including guidance to study teams for the build of non-standard CRF forms, and exemption management. Who You Are Minimum Requirements Bachelors degree in a relevant scientific or technical field, computer sciences, Data Management. 5-8 years of proven experience in the pharmaceutical or biotechnology industry. Proficiency with data management systems, with preference for experience in Rave Medidata. Good experience in eDC set-up activities, CRF build, and edit checks programming. Advanced knowledge of industry data standards and tools, including CDISC SDTM, CDASH, ODM-XML, and define.xml. Good understanding of regulatory requirements (FDA, EMA, CFDA, PMDA) and ICH-GCP guidelines. Strong analytical, problem-solving, and organizational skills. Strong attention to detail and accuracy in adhering to data standards and guidelines. Preferred Requirements Rave Medidata eDC build certified, SAS programming Proficiency in data standard governance principles and their application in the pharmaceutical industry. Demonstrated ability to support and lead data standardization initiatives within assigned projects or domains. Willingness to collaborate and learn from experienced team members to expand knowledge and expertise. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! Show more Show less

You should have a minimum of 2 to 3 years of Clinical Data Management experience. It is essential to have exposure to Study Start-up, Conduct, and Study Closeout. If you do not have experience in all three phases, you should have good exposure to a minimum of two phases. Hands-on experience with Rave (Medidata) or Veeva EDC is a must. You must possess the following skills: - Setup experience with knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, and UAT knowledge (not mandatory). - Conduct experience including Data Cleaning (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, and Dataset review. - Study Lock experience with expertise in Freezing/Locking. Having a client-facing role and mentoring experience are considered added advantages. Your responsibilities will include: 1. Executing Data Management Activities such as Data Cleaning, Manual and System checks, Updating relevant trackers, Discrepancy and query management, Issue resolution, and Database lock activities. 2. Participating in innovation and process improvement initiatives. 3. Identifying and developing action plans in coordination with the TL for activities not meeting the client SLAs. 4. Archiving all necessary information for audit purposes according to quality and security requirements. 5. Supporting multiple clinical trials across diverse therapeutic areas and providing technical oversight when required. 6. Having hands-on experience in Study Setup. 7. Working exposure in RAVE/VEEVA EDC and knowledge of Spotfire reporting tool. 8. Experience in third-party data handling (Lab, PK, Image, etc.) and client-facing role with experience in client communication.,

You have 2 to 3 years of minimum Clinical Data Management experience. You must have exposure to Study Start up, Conduct, and Study Closeout. If you do not have experience in all three phases, you should have good exposure to a minimum of two phases. Hands-on experience with Rave (Medidata) or Veeva EDC is a must. In terms of setup, you should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, and some understanding of UAT (User Acceptance Testing) although it's not mandatory. Your experience in conducting tasks should include Data Cleaning, Query Handling, Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review, among others. You should be familiar with Study Lock activities such as Freezing/Locking and have good experience with Study lock procedures. Having a client-facing role and the ability to mentor others would be advantageous in this position. Your responsibilities will include executing Data Management Activities like Data Cleaning, Manual and System checks, updating relevant trackers, managing discrepancies and queries, resolving issues, and conducting Database lock activities. You will be expected to participate in innovation and process improvement initiatives, and to identify and develop action plans in coordination with the Team Lead for activities not meeting the client SLAs. Furthermore, you will need to archive all necessary information for audit purposes according to quality and security requirements to ensure reliable and timely retrieval of documentation and information. In addition, you will support multiple clinical trials across diverse therapeutic areas and provide technical oversight when required. Having hands-on experience in Study Setup and working exposure in RAVE/VEEVA EDC, as well as knowledge of the Spotfire reporting tool, will be beneficial. Experience in third-party data handling (Lab, PK, Image, etc.), client-facing roles, and effective client communication will also be valuable in this role.,