Senior CDA, Senior Statistical Programmer A global CRO.

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Senior Clinical Data Analyst, you will be responsible for creating Data Management Plans (DMP), eCasebook Guidelines (eCCGs), Edit Check Specifications, Data Review Listing Specifications, and other set-up documents. You will also perform User Acceptance Testing (UAT) and review the Electronic Data Capture (EDC) database to ensure data consistency and completeness. Your duties will include Listings Review, Query Management, managing Serious Adverse Events (SAE) and external vendor data reconciliation, analyzing data trends, and generating reports. Additionally, you will be involved in User Account Management, Study Metrics, Quality Control (QC), and EDC Archival. In the role of Senior Statistical Programmer, your responsibilities will include developing, validating, and maintaining programs and tools to generate reports and listings for data review. You will create data transfer specifications, train and mentor other programmers, and establish programming specifications. It will be vital to maintain all necessary programming documentation while adhering to quality and industry standards. You will act as a Subject Matter Expert (SME) for technical inquiries, monitor tasks that may fall within or outside the project scope, and develop, validate, deploy, and manage EDC study builds. Your expertise will be required in crafting tools and macros to enhance quality and efficiency, and your proficiency with industry data standards such as CDASH, SDTM, ADaM, etc., will be crucial. To qualify for this position, you should possess a minimum of 3 to 4 years of relevant experience in the field.,

Posted 2 weeks ago

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Clinical Data Manager I (CDMI) Excelya

1.0 - 5.0 years

0 Lacs

karnataka

On-site

Excelya is a leading independent Contract Research Organization (CRO) in Europe, dedicated to providing a people-centered approach since its inception in 2014. As a part of the ambitious health company, with a team of 900 Excelyates, our unique service model offers a diverse array of projects, enabling professional growth and personal development. In collaboration with experts, Excelya aims to advance scientific knowledge and enhance the patient journey, striving to become the clinical research leader in Europe. As a Clinical Data Manager at Excelya, you will be responsible for executing Data Management tasks in compliance with regulatory standards and Client SOPs. Working under the supervision of senior staff, you will be involved in data cleaning, review, discrepancy management, and reconciliation activities on assigned studies. Additionally, you will collaborate with the Lead Data Manager, generate study metrics and reports, and participate in study documentation archiving. Excelya is currently seeking a Full Service Provider role of Clinical Data Manager I (CDMI) based in Bangalore, India. The role requires a candidate with a Bachelor's degree in a Scientific discipline, preferably with at least one year of experience as a Data Manager or relevant expertise. Knowledge of ICH GCP guidelines, clinical trial databases, data flow, and proficiency in office computer applications are essential requirements for this position. Effective communication skills, both verbal and written, along with a commitment to professionalism, ethics, and compliance, are key attributes we are looking for in potential candidates. The successful candidate for the role of Clinical Data Manager at Excelya should be fluent in both the local language and English. This full-time position is located in Bangalore and offers an opportunity to contribute to the field of Clinical Research. If you are passionate about making a difference in the healthcare industry and meet the mentioned requirements, we encourage you to apply for this exciting opportunity. If you are interested in this position, please reach out to Bhavya Reddy, HR Manager, for further details.,

Posted 2 weeks ago

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