Job
Description
Job Title: Clinical Data Associate I (CDA I) Location: Bengaluru /Mysuru- Hybrid Function: Clinical Data Management ESSENTIAL DUTIES AND RESPONSIBILITIES The Clinical Data Associate I is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers to ensure on time and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes. Participating in the preparation/review of Data Management process control documents, including but not limited to the Data Management Plan, Data Validation Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, External Reconciliation plans, SAE Reconciliation, CRF Completion Guidelines, etc. Effectively managing all data management aspects of assigned project(s) from set up to database lock. Participating in in-house and external training courses, as required. Having knowledge of Medidata Rave or any other EDC tool, and exposure to Business Object/JReview experience, which is an added advantage. Possessing knowledge of Clinical Protocol, data management plan, edit checks requirements, and data standards management. Producing project-specific status reports for management, PM, and/or clients on a regular basis and monitoring study metrics. Demonstrating strong verbal and written communication skills. Coordinating with the Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required. Demonstrating initiative and motivation. Being capable of directing and promoting teamwork in a multi-disciplinary team setting. Possessing excellent written and verbal communication skills. Having a strong knowledge of ICH guidelines. EDUCATION AND EXPERIENCE REQUIRED Preferably a life science graduate or equivalent qualification. 1-3 years of clinical data management experience within Contract Research Organizations (CRO), Pharmaceutical, or biotech industries. Effective working knowledge of Microsoft Office Suite, including Word and Excel. Demonstrated proactiveness, problem-solving, analytical, organizational, and time management skills. Demonstrated flexibility and ability to work well in a fast-paced, growing organization. Demonstrated ability to work in a global team environment. Demonstrates a basic understanding of Clinical Trials and the flow of data. Demonstrated ability to comply with ICH-GCP/ regional regulatory guidelines and Sitero SOPs. Comprehension of study documentation standards including Trial Master File organization and archival processes. Cross functional collaboration & Stakeholder management. COMPENSATION & BENEFITS Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE Full Time, Permanent COMMITMENTS Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER
