Associate Manager – Clinical Data Management

Location
Pan India
Salary
INR 3,000,000 / year
Company
Akash pawar

Job description

Role & Company / Project Overview: We are hiring for an Associate Manager – Clinical Data Management opportunity for one of our esteemed clients. Key Responsibilities & Daily Duties: • Conducting and overseeing study-level Clinical Data Management activities from start-up to close-out • Performing clinical trial data review, query management, data cleaning, and issue resolution • Working closely with CROs and study teams to ensure timely and high-quality data deliverables • Managing and reviewing eCOA / external data and coordinating with external data vendors • Performing external data reconciliation against EDC data and following up on discrepancies • Supporting and/or performing SAE reconciliation with relevant safety teams • Contributing to Data Cleaning Plans, Data Validation Plans, Edit Checks, Listing Review Checks, and Reconciliation Plans • Supporting interim and final database lock activities • Supporting the setup, testing, and maintenance of clinical data collection systems including EDC, IRT, eCOA, and ePRO • Reviewing and maintaining clinical trial documentation and supporting eTMF activities • Supporting inspection readiness and internal/regulatory inspections • Coordinating and overseeing the work of data coordinators/CRO teams • Mentoring junior team members and ensuring timely completion of assigned CDM deliverables Required Qualifications, Skills & Experience: • 8+ years of relevant Clinical Data Management experience • Strong Study Leading experience in conducting, managing, and closing out end-to-end CDM activities • Veeva experience is Mandatory • Experience managing clinical trial data activities from study start-up through database lock and study close-out • Strong experience working with CROs, vendors, study teams, and other stakeholders Working Hours, Shifts & Location Details: • Location: PAN India Compensation & Benefits: • Budget: 30 LPA Application Instructions: Interested candidates can share their updated CV to the provided recruitment contact emails.

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