4.0 - 8.0 years

0 Lacs

karnataka

On-site

You will serve as a member of the project team with the primary responsibility of clinical data review, query generation/resolution, and reconciliation to ensure the delivery of clinical data aligns with client quality and integrity specifications, project timelines, and productivity targets. Additionally, there is a potential opportunity to contribute to the development of the project Data Management Plan, including data review guidelines and setting up data management systems according to project requirements. You may also act as the operational data management leader on small projects, providing technical oversight of data management activities to deliver clinical data in line with client quality standards, project timelines, and budgets. Your core responsibilities will include reviewing clinical trial data as per [Global] Data Management Plans and relevant standardized data management processes to identify any erroneous, missing, incomplete, or implausible data. Running ancillary programs to support data review, generating, resolving, and tracking queries for problematic data, performing aggregate reviews of clinical data to identify trends or inconsistencies, applying quality control procedures to ensure data quality standards are met, and reviewing project documents such as protocols, CRFs, and Data Management Plans are also key aspects of your role. Furthermore, you will assist in developing Data Management Plans and Quality Management Plans, reviewing database designs, creating data review guidelines, developing data management system edit checks, and collaborating with the project team to meet milestones and communicate with leads from various disciplines. You will also ensure service quality meets specified requirements, inform the Lead Data Reviewer of budget overages, perform quality control on data management activities, support audits, and train project staff on data management processes. To qualify for this role, you should have a university/college degree in life sciences, health sciences, information technology, or related subjects. Relevant work experience or education equivalent to a bachelor's degree will also be considered. You should have 4 to 6 years of experience in Clinical Data Management, knowledge of clinical trial processes, clinical operations, biometrics, and system applications, strong time management skills, the ability to work in a team, good organizational, communication, and interpersonal skills, knowledge of medical terminology, science background, and proficiency in oral and written communication. Preferred qualifications include in-depth knowledge of Fortrea, Electronic Data Capture experience, and familiarity with the organization's structure and Standard Operating Procedures. The physical demands of this job involve an office and/or home-based work environment. Your role is crucial in ensuring the quality and integrity of clinical data delivery, adhering to project timelines, and collaborating effectively with the project team to achieve set objectives.,

Posted 4 weeks ago

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