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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
1.0 - 3.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Premier Research is looking for a Associate Data Manager - Fixed Term Contract - India to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech. Join us and build your future here. What You&aposll Be Doing Assist in preparing clean databases by performing a review of clinical trial data to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Review responses to queries for appropriateness, resolve any discrepancies, and modify the database accordingly Support data entry testing to ensure data can be input into the database as intended by the database design. Support query testing (edit checks) to determine data entered to a clinical database outside of expected values or ranges are prompted for further review. Assist in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements Prepare and maintain documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required What We Are Searching For Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience Preferred 1 to 2 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Show more Show less
Posted 1 month ago
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