Senior Clinical Data Associate
Location: Bangalore, Karnataka
Department: Service Delivery
Employment Type: Full-Time
Company Overview
Sitero is an emerging leader in clinical services and technology solutions for the life sciences industry. With deep experience across diverse therapeutic areas, Sitero combines innovation, compliance, and advanced software platforms to support high-quality clinical research. From early-phase studies to Phase III trials, our teams deliver high-touch services designed to ensure data integrity, stakeholder safety, and operational excellence.
Position Summary
The Senior Clinical Data Associate plays a key role in the planning, oversight, and execution of Data Management activities across assigned clinical studies. This role supports end-to-end data handling—from study setup to database lock—while ensuring adherence to regulatory standards, sponsor expectations, and project timelines. The role may also include serving as a Lead Data Manager on select studies.
Key Responsibilities
Data Management & Study Oversight
Participate in preparing and reviewing project-level Data Management documents, including:
Data Management Plans, Data Validation Specifications, UAT documents, Data Transfer Agreements, External Reconciliation Plans, SAE Reconciliation guidelines, and CRF Completion Guidelines.
Manage all Data Management activities from study start-up through database lock.
Serve as Lead Data Manager on assigned projects, acting as the primary sponsor-facing contact.
Provide regular project updates during internal and sponsor meetings.
Quality Control & Process Management
Perform ongoing data review, data cleaning, query management, and QC checks.
Ensure study execution aligns with protocols, DMPs, edit check specifications, and data standards.
Maintain compliance with ICH-GCP, regulatory guidelines, and SOPs.
Participate in eTMF audits and address audit findings promptly.
Team Leadership & Collaboration
Supervise Data Management team members and support workload allocation.
Train, mentor, and guide new and existing team members to ensure consistent delivery.
Coordinate with Medical Data Reviewers and Medical Monitors for coding and medical terminology review.
Collaborate cross-functionally with Clinical Operations, Biometrics, and Project Management.
Technical & System Responsibilities
Utilize Medidata Rave or other EDC platforms for study database activities.
Manage EDC system access and training for investigators, CRAs, coordinators, and data entry teams.
Support creation and review of CRFs, edit checks, and database specifications.
Implement CDISC standards (SDTM) across study activities.
Use Business Objects/JReview or similar tools as needed.
Reporting & Documentation
Generate project status reports for internal leadership, PMs, and clients.
Track study metrics and ensure timely communication of project risks or delays.
Support TMF organization and documentation standards from setup to archival.
Required Education & Experience
Bachelor's degree in Life Sciences or an equivalent qualification (mandatory).
8–10 years of Clinical Data Management experience within CRO, pharmaceutical, or biotech environments (required).
Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial data flow.
Hands-on experience with EDC platforms (Medidata Rave preferred).
Working knowledge of CDISC SDTM standards.
Proficiency in Microsoft Word, Excel, and relevant data management tools.
Demonstrated project management, analytical, and problem-solving skills.
Ability to work effectively in a global, fast-paced environment.
Experience in mentoring or coaching team members.
Preferred Skills
Experience leading Data Management teams on multi-site global studies.
Familiarity with Business Objects/JReview or similar reporting tools.
Strong verbal and written communication skills.
Ability to manage timelines, prioritize tasks, and respond to project demands.
Compensation & Benefits
Sitero offers a competitive compensation package that includes:
Attractive base salary
Variable pay
Paid time off
Comprehensive healthcare benefits
Retirement plan offerings
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