Full-Time

Manager – Quality Control and Data Entry

Confirmed live in the last 24 hours

Celerion

Celerion

1,001-5,000 employees

Clinical research organization for drug development

Biotechnology
Healthcare

Mid, Senior

Lincoln, NE, USA

Onsite position in Lincoln, NE.

Category
Data Entry
Clerical & Data Entry
Required Skills
Google Cloud Platform
Requirements
  • Bachelor’s field in a related degree required.
  • 3+ years of professional experience in clinical research data work (phase one preferred)
  • 1-2 years supervisory or trainer/leader experience required.
  • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
  • Prior task/project management experience involving staff planning and forecasting.
  • Ability to manage multiple projects/priorities required
  • High attention to detail required
  • Excellent oral and written communication skills required
  • Excellent organizational skills required
  • Proficiency in MS office applications required
  • *Work experience may substitute for degree requirements
Responsibilities
  • Responsible for staff management in accordance with the organization's policies and applicable laws
  • Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees
  • Communicate and provide support/guidance to appropriate groups/staff as required to ensure established, revised and/or new processes are followed to ensure quality on-time/zero defect standards
  • Plan, organize and facilitate workloads and schedules of staff to ensure that timelines are met and are compliant with regulatory and internal procedure requirements.
  • Attend and participate in study specific meetings related to study set up, timeline production and management, and study status
  • May be required to carry out study tasks, including but not limited to, complete QC review of source data and raw data for studies, performing accurate data entry, attending internal study initiation meetings to determine QC criteria and timelines for studies
  • Write QC and DE SOPs and Procedure guides and participate in SOP and Procedure Guide Reviews
  • Create and track metrics associated with QC and DE responsibilities
  • Present the QC processes to sponsors and auditors
  • Lead Process Improvement initiatives to improve the quality of the source data

Celerion specializes in early phase drug development as a clinical research organization (CRO). The company provides a range of services to pharmaceutical and biotechnology companies, including clinical trial design, feasibility studies, project management, and regulatory affairs. Celerion uses advanced bioanalytical techniques, particularly High Resolution Mass Spectrometry (HR MS), for metabolite profiling and identification, which enhances their research capabilities. This focus on bioanalytical sciences and their extensive experience allows Celerion to assist clients in making informed decisions during the early stages of drug development. Unlike many competitors, Celerion emphasizes speed and quality in their research processes, aiming to help clients bring new treatments to market more quickly, ultimately benefiting patients around the world.

Company Stage

Acquired

Total Funding

N/A

Headquarters

Lincoln, Nebraska

Founded

2010

Growth & Insights
Headcount

6 month growth

11%

1 year growth

11%

2 year growth

13%
Simplify Jobs

Simplify's Take

What believers are saying

  • Celerion's CLIA certification enhances its bioanalytical laboratory capabilities for clinical trials.
  • The rise of precision medicine aligns with Celerion's expertise in specialized bioanalytical services.
  • Expansion into GLP/GCP compliant molecular testing positions Celerion in the growing cell therapy market.

What critics are saying

  • Emerging CROs in Asia offer cost-effective solutions, threatening Celerion's market share.
  • AI-driven drug discovery tools may reduce demand for traditional early-phase trials.
  • Pharmaceutical industry consolidation could lead to fewer clients and larger contracts for Celerion.

What makes Celerion unique

  • Celerion specializes in early-phase drug development with over 40 years of experience.
  • The company excels in metabolite profiling using High Resolution Mass Spectrometry (HR MS).
  • Celerion's global operations offer comprehensive services from trial design to regulatory affairs.

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