QC Specialist

eClinical Solutions; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

eClinical Solutions is seeking a Quality Control Specialist in Bengaluru, India. This role focuses on quality control of Biometrics deliverables and requires 3-5 years of experience in the pharmaceutical or biotechnology sectors.

The ideal candidate will possess a four-year degree and extensive knowledge of the Medidata Rave EDC platform. Strong communication and organizational skills are essential.

Join a team committed to delivering high-quality projects in clinical development initiatives.

Qualifications

• Minimum 3-5 years in the pharmaceutical/biotechnology industry or equivalent.
• Knowledge of ICH/GCP guidelines and clinical trial methodology preferred.
• Experience performing quality control activities of clinical trial deliverables preferred.

Responsibilities

• Perform quality control activities of Biometrics client’s deliverables.
• Manage documentation created during the QC process.
• Collaborate with the project team to ensure timely completion.

Skills

Detail oriented

Excellent verbal communication

Excellent written communication

Multitasking

Strong prioritization

Planning and organization skills

Team player

Education

Four-year college degree or higher (Computer Science or health-related field)

Tools

Medidata Rave EDC

SQL Server

Oracle

Microsoft Office (Word, Excel, PowerPoint)

Job description

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

OVERVIEW

Quality Control Specialists are operationally responsible for performing quality control activities associated with Biometrics client’s deliverables. They maintain a project-level perspective, focus, and communicate effectively as the quality control subject matter expert.

KEY TASKS & RESPONSIBILITIES

• Perform quality control activities (documentation review, testing) of Biometrics client’s Rave EDC and data management deliverables including eCRFs, Data Validation Specification checks, custom functions, data extracts, data integrations, data mapping, custom data management reports and listings.
• Participate in the design and development of quality control procedures.
• Manage documentation created during the QC process.
• Liaise with study teams and other staff to fulfill job responsibilities and activities.
• Develop and lead execution of training and knowledge transfer opportunities for the quality control team.
• Inform the Manager of training issues, project activities, quality issues and timelines as directed.
• Collaborate with the project team to ensure deliverables are completed on time with high quality.
• Other duties as assigned.

CANDIDATE’S PROFILE

Education & Language

• Four‑year college degree or higher preferred; analytic discipline a plus (Computer Science or health‑related field).
• Excellent knowledge of English.

Professional Skills & Experience

• Minimum 3-5 years in the pharmaceutical/biotechnology industry or equivalent.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferred.
• Experience performing quality control activities of clinical trial deliverables preferred.Excellent verbal and written communication skills.
• Detail oriented; ability to multitask with strong prioritization, planning and organization skills.
• Excellent team player.

Technical Skills & Experience

• Extensive knowledge of Medidata Rave EDC platform and other modules of Rave preferred.
• Familiarity with databases: SQL Server, Oracle highly preferred.
• Extensive validation experience of eCRFs, edit checks, custom functions, data management.
• Strong understanding of database structures and programming languages.
• Proficiency in Microsoft Office applications, specifically Word, Excel and PowerPoint.

As set forth in eClinical Solutions’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.