Senior Clinical Data Associate (Rave)

The Senior Clinical Data Associate will lead and support clinical data management activities across global studies, ensuring accurate, timely, and compliant data delivery. This role requires strong knowledge of clinical databases, Rave systems, quality processes, and the ability to coordinate effectively with internal and external stakeholders.

Lead and support Clinical Data Associates in completing data management activities for assigned clinical trials.

Manage study data activities from database build and testing through study conduct, data cleaning, and closeout.

Review and follow study-specific Data Management Plans (DMPs), Data Validation Specifications (DVS), and operational procedures.

Create and execute test data scenarios and perform User Acceptance Testing (UAT) for clinical databases, edit checks, roles, and workflows.

Review discrepancy reports, validation listings, and clinical data outputs to identify, resolve, and document data issues.

Perform data cleaning activities, including query management, self-evident corrections, reconciliation activities, and data review.

Manage and validate external data sources, including laboratory data, electronic diaries, pharmacokinetic data, and other vendor datasets.

Support database design activities, including CRF/eCRF review, data structures, annotations, and configuration specifications.

Create, update, and review study documentation, including completion guidelines, transfer agreements, and data management documentation.

Perform quality control checks, including SAS mapping QC and Data Management Study File (DMSF) reviews.

Generate reports and support data analysis activities using relevant reporting tools.

Conduct Serious Adverse Event (SAE) reconciliations and support clinical data review processes.

Collaborate with clinical programming, biostatistics, clinical operations, and project management teams.

Participate in sponsor meetings, audits, inspections, and internal quality reviews when required.

Support the Project Data Manager by coordinating activities, preparing metrics, and managing assigned study deliverables.

Mentor and train junior data management team members while providing guidance and quality oversight.

Act as a subject matter expert for clinical data management processes, platforms, and study-specific requirements.

Requirements

• The ideal candidate is an experienced clinical data management professional with strong Rave expertise, excellent organizational skills, and the ability to manage complex global studies. You should have experience working in regulated healthcare environments and be comfortable collaborating with multidisciplinary teams.

• Bachelor’s degree in biological sciences, healthcare, life sciences, or a related discipline.

• 5+ years of experience in Clinical Data Management and relational database management systems preferred.

• Strong experience working across the full clinical study lifecycle, including study build, conduct, and closeout activities.

• Mandatory experience with Rave clinical data management systems.

• Strong understanding of clinical data processes, ICH guidelines, and Good Clinical Practice (GCP) standards.

• Experience with clinical database design, validation, testing, and data cleaning activities.

• Knowledge of medical terminology and clinical research processes.

• Experience in therapeutic areas such as Oncology, Cardiovascular, Renal, or Metabolism is preferred.

• Strong communication, stakeholder management, and project coordination skills.

• Ability to mentor team members and provide leadership within data management activities.

• Excellent written and verbal communication skills with the ability to present information clearly and influence stakeholders.

• Strong organizational and time management skills with the ability to manage multiple priorities and deadlines.

• Proficiency with Microsoft Office tools, including Word, Excel, Outlook, and related applications.

• Ability to work independently while collaborating effectively within global multidisciplinary teams.

• Familiarity with clinical reporting tools, SAS mapping QC, and data transfer processes is preferred.

• Willingness to travel occasionally, up to 25%, if required.

Benefits

• Competitive compensation package.

• Fully remote work opportunity from India.

• Opportunity to contribute to global clinical research programs and healthcare innovation.

• Career development and progression opportunities.

• Access to technical and therapeutic area training.

• Supportive management and collaborative global teams.

• Employee recognition and rewards programs.

• Inclusive work environment focused on professional growth and continuous learning.

• Opportunity to work on projects that help accelerate the delivery of life-changing therapies.

• Exposure to emerging technologies, data-driven solutions, and advanced clinical research practices.