Senior Clinical Data Analyst

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

📋 Description

• Assist the Data Management Lead with study planning, implementation, and project management duties.

• Prepare EDC build schedules and engage in database and edit check specification tasks.

• Execute user acceptance testing (UAT) for database, coding, site payment, and safety integration processes.

• Develop and uphold study documentation, ensuring proper organization in the electronic Trial Master File (eTMF) according to study specifications.

• Oversee data review processes, manage vendor outputs, and facilitate Data Quality Review meetings.

• Handle post-production tasks, data migration, and database locking to guarantee regulatory adherence and alignment with study timelines.

• Offer training and mentorship to junior Clinical Data Management personnel and assist cross-functional study teams.

• Contribute to study operations from the planning phase through to the closeout stage.

• Aid in patient safety monitoring, regulatory compliance, and the accuracy of clinical data.

⛳️ Requirements

• A minimum of 8 years of comprehensive clinical data management experience, from protocol evaluation to database locking.

• Practical experience with Medidata RAVE and Oracle Clinical EDC systems.

• Familiarity with ICH-GCP, FDA regulations, and the processes involved in clinical trials.

• Proven ability to draft and assess data management documents (DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines).

• Exceptional communication, organizational, and problem-solving abilities.

• Background in clinical research, healthcare, or a regulated industry.

• Proficiency in protocol assessments, CRF/eCRF design, and database locking procedures.

• Advanced skills with EDC systems, especially Medidata RAVE and Oracle Clinical.

• Strong competencies in data review, query management, trend analysis, and data quality supervision.

• Familiarity with electronic data capture systems, eTMF platforms, and clinical trial management tools.

• Experience in overseeing CRO or CDM vendors and managing study deliverables within set deadlines.

• Previous involvement in supporting audits, inspections, and regulatory submissions.

• Experience in project management and metrics reporting within clinical research settings.

• Leadership and mentoring experience with junior data management staff.

🏝️ Benefits

• Flexibility in work arrangements.

• Opportunities for growth and continuous learning.

• Career path exploration within clinical research and data management.

• Training and mentoring opportunities.

• A diverse team environment.