Clinical Data Management Specialist ACL Digital

3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a Data Management Specialist, your responsibilities will include defining project specifications for Data Management services such as Protocol Conversion, Database Build, CRF Design, and Data Review and Data Reconciliation tools. You will need to have a clear understanding of external data collection, its integration into clinical trials, and the processes required for management and reconciliation to maintain accuracy and relevance. Your role will involve executing data cleaning strategies to expedite subject data cleanliness and ensure the delivery of high-quality and timely outcomes. You will be responsible for conducting holistic data review and trending analysis through reporting and elluminate analytics to proactively identify issues, risks, and develop effective mitigation strategies. Utilizing artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection will be a key aspect of your responsibilities to enhance the efficiency and quality of trial data. Monitoring and interpreting key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports will enable you to provide actionable recommendations to study leads or project managers. You will be involved in query management, defining specifications, and collaborating with the technical team on configuring a centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. It will also be essential for you to prepare and maintain data management documentation and update them throughout the trial lifecycle. Ensuring the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules will be part of your role. You will actively evaluate and contribute to enhancing processes to increase efficiency and effectiveness. Collaboration and teamwork are crucial in this role to ensure that deliverables are completed on time and with high quality. Compliance with industry quality standards, regulations, guidelines, and procedures will also be a key focus, along with any other duties as assigned.,

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Clinical Data Associate II Precision For Medicine

2.0 - 6.0 years

0 Lacs

chennai, tamil nadu

On-site

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. You will follow Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, study specific plans, and guidelines. Your responsibilities include supporting the Lead DM, performing data entry for paper-CRF studies when necessary, conducting quality control of data entry, developing CRF specifications, assisting in building clinical databases, and maintaining quality controlled database build documentation. You will also specify requirements for edit check types, create and revise data management documentation, train clinical research personnel, review and query clinical trial data, run status and metric reporting, perform medical coding, assist in SAE/AE reconciliation, liaise with third-party vendors, and may assist with SAS programming. Additionally, you may identify and troubleshoot operational problems, review and provide feedback on protocols and reports, participate in developing SOPs, communicate with study sponsors, vendors, and project teams, present software demonstrations/trainings, and may require some travel. You should possess a Bachelor's degree or a combination of related experience, have at least 2 years of experience, proficiency in Microsoft Office, excellent organizational and communication skills, and professional use of the English language. Experience in a clinical, scientific, or healthcare discipline is preferred. If you are an individual with a disability and need a reasonable accommodation to complete the application process or require an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. Please be aware of potential fraudulent job offers, and note that our organization follows a formal interview process before extending any job offers.,

Posted 1 week ago

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