Clinical Data QC Reviewer

Sanofi
Full Time
₹7 lakhs - ₹11 lakhs
Hyderabad
Posted 22h ago

Clinical Data QC Reviewer

Sanofi

Job description

Sanofi are looking for a highly meticulous and detail orientated Clinical Data QC reviewer at Hyderabad. The successful candidate will have responsibility for ensuring quality and accuracy of clinical data.

Company Description  

Sanofi Business Operations (BO) is an internal Sanofi resource organization setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CMO, and R&D, Data & Digital functions. Their goal is to provide strategic and functional support to Medical, HEVA & Commercial organisations globally to deliver tactics.

Job Summary

The Clinical data QC reviewer will ensure accuracy of clinical data. This will include reviewing deliverables to ensure quality according to Quality Control Plan (QCP). You will perform data validation, review data listings and reports. UAT will be performed for CRF amendments and system updates using Medidata RAVE (EDC). Data management KPIs will be tracked. Risks and efficiencies will be flagged to the relevant stakeholders. Operational excellence and compliance will be ensured. You will also work with others across the organisation to increase efficiency of data management within registries.

Key Responsibilities  

As a Clinical data QC reviewer, you will be responsible for:

  • Review deliverables according to the Quality Control Plan (QCP).

  • Validate clinical data within the registry.

  • Review SAS data listings, ad-hoc and scanned reports to ensure they are consistent and accurate.

  • Have an understanding of how data is collected within the system and clinical data collection processes including electronic Case Report Forms (eCRFs) in Medidata RAVE (EDC).

  • Perform User Accepted Testing for CRF changes and system updates.

  • Complete test cases according to clients training requirements.

  • Update Issue Log including data issues and resolution.

  • Seek alignment with internal stakeholders and appropriately prioritise registry study data management activities in line with approved processes.

  • Support team initiatives and objectives, identify and recommend process improvements and participate in company initiatives that add value to the business.

  • Maintain the project database. Perform regular critical reviews of the data management objectives within registry studies identifying potential risks and efficiencies.

  • Track data management KPIs.

  • Ensure operational excellence and compliance.

  • Have an understanding of internal and external customer expectations to positively impact the development of the data management function within registries.

  • Work with colleagues, stakeholders and partners across the organisation to increase efficiency of data management within registry studies.

Educational Qualification          

Educational qualifications required for Clinical Data QC reviewer are:

  • Bachelor's degree in a scientific discipline.

  • A related Life science degree with substantial experience with data management of clinical trials.

Skills Required

To be a Clinical Data QC reviewer you will need:

  • 8+ years of experience with Medidata RAVE (EDC) or other EDC systems.

  • Experience in quality control, quality assurance or data validation within the clinical research or pharmaceutical industry.

  • Experience working with clinical data management and validation processes.

  • Fluent in written and verbal English.

  • Knowledge of clinical trial data management and/or RWE data management.

  • Knowledge of data management tools (SQL, SAS, R, Python, etc).

  • Ability to identify and resolve data issues. Implement corrective actions. Identify and rectify errors in clinical data sets.

  • Knowledge of validation protocols, SOPs and regulations.

  • Knowledge of FDA, EMA and ICH guidelines. Knowledge of GCP and GMP standards.

  • Excellent documentation skills.

  • Strong organisational and project management skills. Ability to manage multiple tasks, to tight deadlines and stakeholders.

Salary Structure  

Average Clinical Data Reviewer salary at Sanofi is ₹7 Lakhs per year to  ₹11 Lakhs per year depending on experience.

Career Development

At Sanofi you will be empowered to pursue the miracles of science and build a fulfilling career. As a Clinical Data QC Reviewer you will be exposed to global clinical trials and cutting edge EDC systems. Sanofi will invest in your continual progression by providing training, guidance from global data management leaders and clear career progression to become a Lead Data Manager, Clinical Data Scientist or Quality Assurance in their global hubs.

How to Apply 

  • Go to our jobs page and search for Clinical Data QC Reviewer at Sanofi.

  • Click on the role to see further details.

  • Fill in your details and upload your CV.

  • Submit your application.

 

Employment Type: Full Time
Industry: Healthcare
Role Category: Non Clinical Jobs
Application: External (Company Site)

Education

Bachelor's Degree

Key Skills

Non Clinical JobsClinical Research
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Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

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