Senior Clinical Data Associate – Sitero – Bangalore (Full-Time)
Location: Bangalore, Karnataka
Department: Service Delivery
Employment Type: Full-Time
Company Overview:
Sitero is a rising force in clinical services and software solutions for the life sciences sector. With a strong foundation in diverse therapeutic areas, Sitero empowers clients through technology-enabled services that support clinical trials from early phase through Phase III. Our focus is on ethics, compliance, and innovation to improve outcomes for all stakeholders in the clinical research community.
Position Summary:
As a Senior Clinical Data Associate, you will play a pivotal role in managing all aspects of clinical data activities across projects. This includes creating essential process documents, leading data management activities, acting as a liaison with sponsors, mentoring teams, and ensuring the highest standards of quality and compliance. You may also serve as a Lead Data Manager on client-facing projects.
Key Responsibilities:
Draft and review critical process documents (e.g., DMPs, DVS, CRF Completion Guidelines, Data Transfer Agreements).
Serve as the Lead Data Manager on assigned projects, interfacing directly with sponsors.
Manage end-to-end data activities from setup to database lock.
Attend sponsor meetings and provide project status updates.
Supervise and mentor data management teams and ensure timely completion of project milestones.
Ensure data quality through ongoing review and QC activities.
Handle training and access management for site staff on EDC platforms.
Participate in audits and respond to queries as required.
Coordinate with Medical Data Reviewers or Medical Monitors for coding-related activities.
Utilize Medidata Rave or similar EDC tools; experience with JReview/Business Objects is a plus.
Follow CDISC standards, ICH-GCP guidelines, and company SOPs.
Provide project-specific reports and monitor key study metrics.
Qualifications & Experience:
Bachelor’s degree in Life Sciences or related field (mandatory).
8–10 years of clinical data management experience in CROs, pharma, or biotech.
Solid knowledge of data flow in clinical trials, ICH-GCP, and regulatory requirements.
Proficient in Microsoft Office Suite (Word, Excel).
Hands-on experience with Medidata Rave or equivalent EDC platform.
Understanding of CDISC SDTM and clinical protocol requirements.
Excellent stakeholder management, verbal, and written communication skills.
Proven experience in team mentoring, project leadership, and multi-disciplinary collaboration.
Flexible and capable of handling fast-paced work environments.
Estimated Salary: ₹10 – ₹14 LPA (based on experience)
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