Clinical Data Specialist

Overview

Sanofi is seeking a Clinical Data Specialist to ensure the accuracy and quality of clinical data through validation, quality control, reconciliation, data review and query management activities.

What you'll do

• Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application.
• Verify data for consistency and identify discrepancies.
• Raise and manage queries to resolve data issues.
• Perform UAT for CRF changes and system updates, document findings, and assist with other tasks as needed.
• Update issue logs with data issues and resolutions.
• Create form entry and query metrics.
• Track eCRF review and backlog metrics.
• Review data listings produced in SAS, ad-hoc reporting, and scanned reports for accuracy.
• Ensure quality control of all activities in-scope, as discussed and required by Sanofi.
• Perform data reconciliation to ensure data integrity.
• Provide input to Data Review Guidelines (DRG) and Quality Management & Control Plan.
• Draft project documents on an ad-hoc basis.
• Facilitate training for new team members and create test cases.
• Seek alignment with internal stakeholders and appropriate prioritization of Registry study data management activities, and compliance with approved processes.
• Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business.
• Ensure that data validation methods produce accurate and reliable results.
• Identify sources of data validity problems and implement data-driven quality improvement processes.
• Ensure operational excellence and compliance readiness.
• Understand, meet, and excel internal and external customer expectations to create positive impact through the evolution of the Registry Data management function.
• Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact Registry study data management efficiency and execution.

What you'll need

• 3-5 years of experience with the Medidata RAVE (EDC) application or other EDC systems.
• Strong attention to detail and analytical skills.
• Excellent communication and documentation skills.
• Ability to work independently and as part of a team.
• Previous experience in a similar role within the pharmaceutical or clinical research industry.
• Familiarity with regulatory requirements and guidelines for clinical data management.
• Excellent written and oral communication skills.
• Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
• Proficiency in data management tools and software, such as SQL, SAS, R, and Python.
• Understanding of data cleaning, transformation, and validation techniques.
• Familiarity with clinical data standards such as CDISC (Clinical Data Interchange Standards Consortium) and HL7 (Health Level Seven International).
• Knowledge of regulatory requirements and guidelines from bodies like the FDA and EMA.
• Degree in a scientific discipline or a related Life science degree with substantial experiences with data management of clinical trials.
• Efficiently managing multiple tasks and deadlines.
• Meticulous review of data to ensure accuracy and completeness.
• High proficiency in written and spoken English.

Details

• Location: Hyderabad.