eClinical Solutions
Life Sciences
QCSpecialist
Neural analysis suggests this role is
optimal for Mid candidates.
“QC Specialist at eClinical Solutions. Skills: Quality control, Clinical deliverables, Medidata Rave. Perform quality control activities. Review documentation”
What You'll Achieve.
Deliverables completed on time; High quality deliverables
Industry & Context.
What They're Looking For.
Must Have
3-5 years in Pharmaceutical/Biotechnology industry, Excellent English knowledge, Excellent verbal communication skills, Excellent written communication skills, Ability to multitask, Prioritization skills, Planning skills, Organization skills
Nice to Have
Four-year college degree or higher, Analytic discipline, Computer Science degree, Health related field degree, Knowledge of ICH/GCP guidelines, Knowledge of 21 CFR Part 11, Knowledge of clinical trial methodology, Knowledge of software development lifecycle, Knowledge of industry standards, Knowledge of CDASH, Knowledge of SDTM, Experience performing QC activities, Extensive knowledge of Medidata Rave EDC, Knowledge of other Rave modules, Familiarity with SQL Server, Familiarity with Oracle, Extensive validation experience of eCRFs, Extensive validation experience of Edit Checks, Extensive validation experience of Custom Functions, Extensive validation experience of Data Management reports, Good understanding of Database structures, Good understanding of Programming languages
What You'll Do.
Perform quality control activities
Test Biometrics client deliverables
Maintain project perspective
Communicate as quality control SME
Participate in design of QC procedures
Manage QC process documentation
Liaise with study teams
Develop training for QC team
Lead knowledge transfer for QC team
Inform Manager of training issues
Inform Manager of project activities
Inform Manager of quality issues
Inform Manager of timelines
Collaborate with project team
Ensure deliverables completed on time
Ensure high quality deliverables
How You'll Work.
Team & Collaboration
Liaise with study teams; Collaborate with project team
Communication Scope
Verbal communication; Written communication
Full 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. 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 develo
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