1.0 - 5.0 years

0 Lacs

hyderabad, telangana

On-site

As a Clinical Data Services Associate at Accenture, you will play a crucial role in the Clinical Data Management team. Your responsibilities will include collecting, integrating, and ensuring the availability of data at the appropriate quality and cost. You will be involved in activities such as reviewing discrepancies, generating queries, and resolving them. Additionally, you will create CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. Your expertise will help in identifying and addressing protocol deviations in the database, performing edit check validation, writing test scripts, and conducting database validation (UAT) against specified CRF/ECRF. You will also manage clinical data management projects, ensuring the collection, integration, and availability of data at the required quality and cost to support the conduct, management, and analysis of studies in clinical research. To excel in this role, you should have the ability to establish strong client relationships, handle disputes effectively, manage multiple stakeholders, meet deadlines consistently, and work collaboratively in a team environment. Your role will involve solving routine problems based on established guidelines and seeking guidance from your team and supervisor when needed. You will receive detailed instructions on your daily tasks and new assignments, with the decisions you make impacting your own work within a focused scope. Please be aware that this position may require you to work in rotational shifts. With a Bachelor of Pharmacy or Master of Pharmacy qualification and 1 to 3 years of relevant experience, you will contribute to Accenture's global professional services company. Accenture is known for its expertise in digital, cloud, and security solutions, offering services across various industries to drive value and success for clients worldwide. Join Accenture's Life Sciences R&D vertical, where you will be part of a team dedicated to supporting the world's leading biopharma companies in bringing their vision to life. By converging around the patient and combining scientific expertise with unique insights into the patient experience, you will help improve outcomes and drive innovation in the healthcare sector. Discover a rewarding career at Accenture, where you can leverage your skills in Clinical Data Management to make a meaningful impact on the future of healthcare. Visit www.accenture.com to learn more about our company and explore the opportunities awaiting you in our dynamic and innovative organization.,

Posted 3 weeks ago

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Senior Medical Writer in Clinical Research @ Vimta Labs Ltd, Hyd Vimta Labs

10 - 15 years

6 - 9 Lacs

Hyderabad

Work from Office

Senior Medical Writer in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 10-15 years in Medical writing field in Clinical Research BA/BE studies CTC : As per market standards Report to: Principal Investigator Clinical Primary Responsibilities: 1. Ensures that Good Clinical Practices (GCP) and NDCT (New Drugs and Clinical Trials Rules) are followed. 2. Writing and developing BA/BE and clinical trail protocols. 3. To perform literature search and preparation of feasibility. 4. Preparation of study specific informed consent forms (ICFs), case report forms (CRFs) and blood sample forms. 5. Preparation of clinical study reports (CSRs), DBE/summary tables, CS-BE tables and module 2.7.1 (M 2.7.1) and other required documents in compliance with applicable regulatory guidelines. 6. Co-coordinating departmental activities to ensure timely delivery of the final reports with quality. 7. Co-coordinating and liaising with operational team (internal & external) as necessary. 8. Collection of demographics, AEs, SAEs, subject disposition, protocol deviations, dosing information from CRFs and TMFs, that are required for the preparation of CSR. 9. Narration of SAEs. 10. Preparation of eCRF (creation of forms, study registration and other required fields) before study execution. 11. Monitoring team for achieving TAT. Secondary Responsibilities 1. Review of Tables and listings (TLs) 2. Ensures that Case Report Forms (CRF) are reviewed in a timely manner and submitted for further process. Interested candidates can share their resumes to keerthana.rojanala@vimta.com Contact: Keerthana

Posted 2 months ago

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