Clinical Data Specialist

Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally.

The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.

Main responsibilities:

 

Sanofi is seeking a dedicated and detail-oriented Clinical Data Specialist to join our team. The successful candidate will be responsible for ensuring the accuracy and quality of clinical data through comprehensive validation and quality control processes.

Key Responsibilities:

 

System and Data Collection: Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application.

Data Verification: Verify data for consistency and identify discrepancies.

Query Management: Raise and manage queries to resolve data issues.

User Acceptance Testing (UAT): Perform UAT for CRF changes and system updates, document findings, and assist with other tasks as needed.

Issue Log Management: Update issue logs with data issues and resolutions.

Metrics Creation: Create form entry and query metrics.

Metrics Tracking: Track eCRF review and backlog metrics.

Data Review: Review data listings produced in SAS, ad-hoc reporting, and scanned reports for accuracy.

Quality Control: Ensure quality control of all activities in-scope, as discussed and required by Sanofi.

Reconciliation: Perform data reconciliation to ensure data integrity.

Guideline Input: Provide input to Data Review Guidelines (DRG) and Quality Management & Control Plan.

Documentation: Draft project documents on an ad-hoc basis.

Training Facilitation: Facilitate training for new team members and create test cases.

·       People: (1) Seek alignment with internal stakeholders, and appropriate prioritization of Registry study data management activities, and compliance with approved processes; (2) 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

·       Performance: (1) Ensure that the data validation methods produce accurate and reliable results (2) Identify sources of data validity problems and implementing data-driven quality improvement processes; (3) Ensure operational excellence and compliance readiness.

Process:(1) Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application. (2) Verify data for consistency and identify discrepancies. (3) Raise and manage queries to resolve data issues. (4) Perform UAT for CRF changes and system updates, document findings, and assist with other tasks as needed. (5) Update issue logs with data issues and resolutions. (6) Create form entry and query metrics. (7) Track eCRF review and backlog metrics. (8) Review data listings produced in SAS, ad-hoc reporting, and scanned reports for accuracy. (9) Ensure quality control of all activities in-scope, as discussed, and required by Sanofi. (10) Perform data reconciliation to ensure data integrity. (11) Provide input to Data Review Guidelines (DRG) and Quality Management & Control Plan. (12) Draft project documents on an ad-hoc basis. (13) Facilitate training for new team members and create test cases.

·       Stakeholder: (1) Commit to Customers – Understand, meet, and excel internal and external customer expectations to create positive impact through the evolution of the Registry Data management function. (2) Cooperate Transversally – Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact Registry study data management efficiency and execution.

About you

·       Experience: 3-5 years of Experience with 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.

●     Soft skills: 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. Previous experience in a similar role within the pharmaceutical or clinical research industry. Familiarity with regulatory requirements and guidelines for clinical data management.

·       Technical skills: Proficiency in data management tools and software (e.g., SQL, SAS, R, 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.

Education: 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 in reviewing data to ensure accuracy and completeness.

Languages: High Proficiency in written and spoken English.

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