Senior Clinical Data Associate
Location: Bengaluru (Bangalore), Karnataka, India
Department: Service Delivery – Clinical Data Management
Employment Type: Full-Time
About the Company
Sitero is an emerging global leader in clinical services and technology-enabled solutions for the life sciences industry. With expertise spanning early-phase research through Phase III clinical trials, Sitero delivers high-touch clinical data and operational services designed to ensure patient safety, regulatory compliance, and data integrity. The organization is driven by innovation, ethics, and a commitment to advancing clinical research worldwide.
Role Overview
The Senior Clinical Data Associate plays a critical role in the end-to-end execution of clinical data management activities, from study setup through database lock. This position involves close collaboration with sponsors, internal cross-functional teams, and leadership, and may serve as a Lead Data Manager on assigned studies. The role is ideal for experienced clinical data professionals seeking a client-facing, leadership-oriented position within a growing CRO environment.
Key Responsibilities
Participate in the preparation, review, and implementation of Data Management deliverables, including Data Management Plans (DMPs), Data Validation Specifications, CRF Completion Guidelines, Data Transfer Specifications, SAE Reconciliation Plans, and External Reconciliation Plans.
Manage all data management activities for assigned studies from study start-up through database lock.
Act as Lead Data Manager for assigned projects, serving as the primary client-facing contact when required.
Attend sponsor and project team meetings to address data management issues and provide study status updates.
Supervise and guide the Data Management team, ensuring quality, compliance, and timely deliverables.
Serve as a liaison between clients, project leadership, and internal teams for all data management activities.
Develop and monitor project timelines, proactively identifying risks and managing schedule changes.
Train, mentor, and support study team members while performing ongoing quality control and data review.
Ensure accurate medical coding in collaboration with Medical Data Reviewers and/or Medical Monitors.
Coordinate EDC access, training, and support for investigators, coordinators, CRAs, and data entry personnel.
Generate and present project status reports, metrics, and dashboards to management and sponsors.
Support eTMF audits and respond to audit findings in a timely and compliant manner.
Ensure compliance with ICH-GCP guidelines, SOPs, and regulatory requirements.
Apply and maintain knowledge of CDISC standards (SDTM preferred).
Promote teamwork and collaboration within multidisciplinary global teams.
Required Education & Experience
Education:
Bachelor’s degree in Life Sciences or a related discipline (or equivalent qualification).
Experience:
8–10 years of hands-on Clinical Data Management experience within a CRO, pharmaceutical, or biotechnology organization.
Proven experience managing clinical studies from setup to database lock.
Technical Skills:
Strong working knowledge of EDC systems (Medidata Rave preferred; other EDC tools acceptable).
Exposure to JReview, Business Objects, or similar reporting tools is an advantage.
Solid understanding of CDISC standards (SDTM) and data standards management.
Proficiency in Microsoft Word and Excel.
Professional Competencies:
Strong project management, stakeholder management, and client communication skills.
Excellent written and verbal communication abilities.
Demonstrated analytical, problem-solving, organizational, and time management skills.
Ability to work effectively in a global, fast-paced, and growing environment.
Experience mentoring and onboarding junior team members.
Compensation & Benefits
Sitero offers a competitive compensation package, including:
Market-aligned salary
Performance-based variable pay
Paid time off
Comprehensive healthcare benefits
Retirement and long-term benefits
Why Join Sitero
Work on global clinical trials across diverse therapeutic areas
Take on a leadership and client-facing role within data management
Be part of an innovative, technology-driven CRO environment
Collaborate with experienced professionals in a quality- and compliance-focused culture
SEO Keywords Optimized
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