Clinical Data Analyst III

This is a fully remote position, open to applicants in India.

📋 Description

• Conduct and oversee clinical data validation, cleaning, review, and reconciliation tasks independently throughout the study lifecycle and during database lock.

• Handle data queries and perform reviews of manual and SAS-generated listings.

• Reconcile data from external vendors and ensure data integrity across various systems.

• Recognize project risks, emphasize delivery issues, and assist in planning mitigation strategies.

• Create and maintain Data Management documentation and records for the Trial Master File.

• Lead User Acceptance Testing efforts for clinical database configurations.

• Evaluate study protocols, EDC screens, and configurations of the database.

• Contribute to data management timelines and coordinate operational tasks during the study initiation phase.

• Monitor and evaluate CRFs while supporting data entry duties as necessary.

• Execute quality control reviews and ensure adherence to SOPs, ICH-GCP guidelines, and regulatory standards.

• Provide mentorship and on-the-job training to Clinical Data Analysts.

• Act as a Subject Matter Expert concerning data management tools, systems, and processes.

• Assist with initiatives aimed at continuous improvement and the implementation of project-specific tools and efficiencies.

• Conduct operational metric analyses and support assessments of scope changes and resource planning.

• Serve as a backup for the Data Management Lead when needed.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related healthcare field.

• Relevant experience in Clinical Data Management within the clinical research or CRO sectors.

• Proven experience in leading data management activities across clinical trials.

• Strong proficiency with Clinical Data Management Systems such as Medidata Rave, Oracle InForm, Veeva, DataLabs, or ClinBase.

• Advanced knowledge of clinical data management processes, including data cleaning, reconciliation, and database lock procedures.

• Expertise in database setup activities and specifications for data validation.

• Familiarity with MedDRA and WHODrug coding dictionaries.

• Understanding of CDISC standards.

• Basic knowledge of SAS and programmed listings.

• Comprehensive understanding of ICH-GCP guidelines, clinical research regulations, and industry best practices.

• Experience in leading virtual data management teams in global studies.

• Strong skills in leadership, collaboration, stakeholder management, negotiation, influencing, problem-solving, root cause analysis, organization, communication, presentation, mentoring, and coaching.

• Capability to independently engage with sponsors and stakeholders regarding data challenges and study requirements.

• Flexibility to adapt in fast-paced, dynamic environments.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Generous paid time off and holiday leave.