Senior Clinical Data Analyst

Parexel; EE. UU.; A distancia; USD 13.000 - 22.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Senior Clinical Data Analyst to join our team in a remote capacity based in India. You will support clinical data management activities that advance new treatments, contribute to study execution, patient safety oversight, and regulatory compliance across the data lifecycle.

Responsibilities include database design/management, data quality oversight, vendor coordination, and ensuring proper eTMF filing.

Formación

• 8+ years of end-to-end CDM experience.
• Hands-on experience with Medidata RAVE and Oracle Clinical EDC systems.
• Knowledge of ICH-GCP, FDA guidelines, and clinical trial processes.
• Experience authoring/reviewing DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines.
• Strong communication, organization, and problem-solving skills.

Responsabilidades

• Support the Data Management Lead in study planning, execution, and project management activities.
• Draft EDC build timelines and perform database and edit check specification activities.
• Conduct user acceptance testing (UAT) for database, coding, site payment, and safety integrations.
• Create and maintain study documents and filing in the eTMF per study requirements.
• Coordinate data review activities, manage vendor deliverables, and support Data Quality Review meetings.
• Manage post-production activities, data migration, and database lock to ensure regulatory compliance and study timelines.
• Provide training and mentoring to junior CDM staff and support cross-functional study teams.

Conocimientos

End-to-end CDM

Data quality oversight

Vendor coordination

Regulatory compliance

Team collaboration

Herramientas

Medidata RAVE

Oracle Clinical

Descripción del empleo

About the Role

We are seeking a Senior Clinical Data Analyst to join our team in India ,Remote capacity. As a Clinical Data Management Associate, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, patient safety oversight, regulatory compliance, and clinical data accuracy. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.

Your responsibilities will include database design and management, data quality oversight, vendor coordination, and regulatory compliance activities. You'll work in a fast-paced, growth-oriented environment focused on delivering high-quality clinical data that drives regulatory submissions and patient safety. With diverse teams and continuous learning opportunities, the Clinical Data Management Associate can explore career paths and expand skills across clinical research and data management.

Key Responsibilities

• Support the Data Management Lead in study planning, execution, and project management activities
• Draft EDC build timelines and perform database and edit check specification activities
• Conduct user acceptance testing (UAT) for database, coding, site payment, and safety integrations
• Create and maintain study documents and ensure proper filing in the electronic Trial Master File (eTMF) per study requirements
• Coordinate data review activities, manage vendor deliverables, and support Data Quality Review meetings
• Manage post-production activities, data migration, and database lock to ensure regulatory compliance and study timelines
• Provide training and mentoring to junior Clinical Data Management staff and support cross-functional study teams

You'll thrive in this role if you bring:

• Expertise in end-to-end clinical data management, including protocol review, CRF/eCRF design, and database lock
• Advanced proficiency with EDC systems, particularly Medidata RAVE and Oracle Clinical
• Strong skills in data review, query management, query trend analysis, and data quality oversight
• Experience working in clinical research, healthcare, or a regulated environment
• The ability to collaborate across teams and communicate clearly with stakeholders at all levels
• A patient-focused mindset and strong attention to detail in managing complex clinical data
• Comfort working with electronic data capture systems, eTMF platforms, and clinical trial management tools

Required Qualifications

• 8 or more years of end-to-end clinical data management experience from protocol review through database lock
• Hands-on experience with Medidata RAVE and Oracle Clinical EDC systems
• Knowledge of ICH-GCP, FDA guidelines, and clinical trial processes
• Demonstrated expertise authoring and reviewing data management documents (DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines)
• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Experience overseeing CRO or CDM vendors and managing study deliverables within timelines
• Experience supporting audits, inspections, and regulatory submissions
• Project management and metrics reporting experience in clinical research environments
• Mentoring and leadership experience with junior data management staff