Back to jobs

QC Specialist

Bangalore, Karnataka

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.  Quality Control Specialists will maintain project level perspective, focus, and communicate effectively as the quality control subject matter expert.

KEY TASKS & RESPONSIBILITIES 

  • Perform quality control activities (i.e. 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 quality control team
  • Inform the Manager of training issues, project activities, quality issues and timelines as directed
  • Collaborate with the project team to ensure the 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 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

   reports and good understanding of Database structures and Programming languages

  • Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint

 

 

 

Create a Job Alert

Interested in building your career at eClinical Solutions? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

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.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

We use Greenhouse’s AI-powered Talent Matching tool to compare your application against our job requirements.

Learn more