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0.0 - 3.0 years
0 Lacs
karnataka
On-site
Premier Research is seeking an Associate Database Developer for an 8-month contract in India to join the Functional Services Provider (FSP) team. In this role, you will contribute to the transformation of life-changing ideas from biotech, medtech, and specialty pharma companies into new medicines, devices, and diagnostics. Your work will play a crucial role in saving and enhancing lives, and we value our team members as our most important asset for achieving success. We are committed to supporting your growth, providing you with the necessary skills and opportunities to thrive at work while maintaining the flexibility and balance that your life demands. Your input shapes our work culture, and your voice is highly valued within our team. Together, we are dedicated to advancing medical innovation that patients urgently need in the biotech field. Join us and build your future here. As an Associate Database Developer, your responsibilities will include configuring project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and database platforms to ensure accurate clinical trial data capture. Your key tasks will involve creating electronic Case Report Forms (eCRFs) based on finalized protocols and study design specifications for Electronic Data Capture (EDC) studies. Additionally, you will develop data entry screens in alignment with approved annotated Case Report Forms (CRF) for paper studies. Effective communication with data management and study management teams throughout all study start-up activities is essential to ensure that team requirements are clearly understood and met. You will design, build, and test clinical databases following Standard Operating Procedures (SOPs), program field derivations, edit checks, consistency checks, validations, procedures, and rules. Furthermore, your role will involve writing data extraction programs, developing a study reporting environment that includes CRF and non-CRF (loaded) data, and transforming collected data into the required reporting format. It is crucial to maintain database documentation for the Trial Master File (TMF) and collaborate with the sponsor and study team to define all technical elements of the Data Management Plan. The ideal candidate for this position will have a Bachelor's degree or international equivalent, preferably in a technical field, or an equivalent combination of education, training, and experience. Practical experience using commercial clinical data management systems and/or EDC products such as Oracle RDC/Inform, Medidata Rave, or DataLabs is preferred. SQL programming experience, positive customer interaction skills, excellent English verbal and written communication abilities, strong analytical and organizational skills, and the capacity to work independently and manage multiple projects in a fast-paced environment are desirable qualities for this role. Familiarity with drug development and clinical trial processes would be advantageous.,
Posted 1 week ago
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