Job Title: Senior Clinical Data Associate
Location: Bangalore, Karnataka
Function: Clinical Data Management / Service Delivery
Employment Type: Full-Time, Permanent
Sitero is an emerging global leader in clinical services and software solutions for the life sciences industry. With expertise across multiple therapeutic areas, we deliver innovative, technology-enabled solutions that allow clients to focus on their core competencies. From early-phase studies through Phase III clinical trials, our team ensures high-quality data management, compliance, and safety for all stakeholders, emphasizing ethics, innovation, and regulatory adherence.
We are seeking a highly experienced Senior Clinical Data Associate to manage data management operations for clinical trials, oversee data quality, and act as a key liaison between project teams and clients. The ideal candidate will have extensive experience in clinical data management, strong project leadership skills, and the ability to supervise and mentor cross-functional teams in a global clinical research environment.
Participate in preparation and review of Data Management process documents including Data Management Plan, Data Validation Specifications, User Acceptance Testing, Data Transfer Agreements, External Reconciliation Plans, SAE Reconciliation, and CRF Completion Guidelines.
Act as the Lead Data Manager on assigned projects, representing the client-facing role for data management activities.
Attend regular meetings with sponsors and project teams, providing updates on project status and data management issues.
Oversee all data management activities from database setup through database lock.
Supervise and mentor the Data Management team, providing training and guidance on processes and tools.
Manage access and training for investigators, coordinators, data entry personnel, and CRAs for EDC systems.
Ensure quality control and review of data, including coding of medical terminology in coordination with Medical Data Reviewers or Medical Monitors.
Maintain knowledge of EDC tools (e.g., Medidata Rave) and exposure to Business Object/JReview is an added advantage.
Apply CDISC standards and ensure adherence to SOPs, ICH-GCP, and regional regulatory guidelines.
Produce project-specific status reports and monitor study metrics for management and clients.
Coordinate and participate in eTMF audits, responding promptly to auditor queries.
Provide expertise on clinical protocols, edit checks, data standards, and therapeutic area-specific knowledge.
Foster teamwork and collaboration in a multidisciplinary, global team environment.
Minimum 8–10 years of clinical data management experience in CRO, pharmaceutical, or biotech organizations.
Life Science graduate or equivalent qualification (B.Sc., B.Pharm, M.Sc., or related field preferred).
Strong knowledge of ICH-GCP guidelines, regional regulations, and clinical trial data standards.
Familiarity with CDISC SDTM standards and clinical trial documentation standards including Trial Master File organization.
Proficiency in Microsoft Office Suite (Word, Excel) and familiarity with EDC/CRM tools.
Demonstrated skills in project management, cross-functional collaboration, stakeholder management, and team mentorship.
Strong analytical, problem-solving, organizational, and time-management skills.
Excellent verbal and written communication skills with the ability to work in a fast-paced global team.
Competitive salary with variable pay
Paid time off
Healthcare and retirement benefits
Professional development and training opportunities
Lead data management operations in a global clinical services organization.
Work on cutting-edge clinical trials across multiple therapeutic areas.
Mentor and develop junior team members, contributing to global project success.
Exposure to international regulatory standards, SOPs, and innovative EDC platforms.
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