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Gclp Jobs (NOW HIRING)

Predicine, Inc

Clinical Trial Associate

Hayward, CA · On-site

$38.50 - $52.50/hr

Understanding of GCP, GCLP, ICH guidelines, FDA regulations, and/or other applicable clinical research regulations and guidelines * Attention to detail, organizational skills, and ability to manage ...

AskBio

Associate Scientist, Immunology

Durham, NC · On-site

Antibody assay development, qualification and validation activities will be performed in compliance with GCLP (Good Clinical Laboratory Practices) laboratories, GLP (Good Laboratory Practices), CLIA ...

Inotivco

Bioanalysis Scientist I

Rockville, MD

Understanding of GLP/GCP/GMP/GCLP regulations; ability to apply practices daily. * Excellent written and verbal communication skills (English required); open, interactive style that facilitates high ...

IQVIA

Medical Laboratory Scientist

Irving, TX · On-site

$46K - $96K/yr

Ensures compliance with CLIA, CAP, GCLP, and internal quality management systems. * Adheres to quality control policies, documents QC activities, and maintains a clean, organized work environment.

IQVIA

Clinical Lab Scientist (CLS)

Valencia, CA · On-site

$46K - $96K/yr

Maintain compliance with CLIA, CAP, GCLP, safety, quality, and company procedures * Participate in audits, inspections, continuing education, and training activities * Support special projects and ...

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Gclp information

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How much do gclp jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for gclp in the United States is $24.06, according to ZipRecruiter salary data. Most workers in this role earn between $16.83 and $25.96 per hour, depending on experience, location, and employer.

What is a GCLP professional?

GCLP professionals are individuals who work in compliance with Good Clinical Laboratory Practice (GCLP) standards. These standards ensure the quality, reliability, and integrity of laboratory data generated in clinical trials. GCLP professionals are responsible for overseeing laboratory operations, maintaining documentation, ensuring regulatory compliance, and supporting clinical research activities. Their work is critical in providing accurate laboratory results that support drug development and patient safety.

What are the key skills and qualifications needed to thrive as a Good Clinical Laboratory Practice (GCLP) professional?

To thrive as a GCLP professional, you need a solid background in clinical laboratory sciences, regulatory compliance, and quality management, often supported by relevant degrees or certifications in laboratory practices. Familiarity with laboratory information management systems (LIMS), GCLP guidelines, and audit procedures is typically required. Attention to detail, strong organizational abilities, and effective communication are important soft skills for success in this role. These competencies ensure the accuracy, reliability, and regulatory compliance of laboratory data in clinical trials, which are critical for patient safety and valid research outcomes.

What are some common challenges faced by professionals working in a GCLP role, and how can they be addressed?

Professionals in a GCLP role often encounter challenges such as maintaining stringent compliance with regulatory standards, managing documentation accurately, and ensuring effective communication between laboratory and clinical teams. Adapting to evolving guidelines and integrating new technologies can also present difficulties. Addressing these challenges involves ongoing training, robust quality management systems, and fostering a culture of open collaboration, which helps ensure data integrity and smooth workflow in clinical research settings.

What is the difference between Gclp vs Clinical Laboratory Scientist?

AspectGclpClinical Laboratory Scientist
CertificationsGCLP certification, Good Clinical Laboratory PracticeASCP certification, CLS license
Work EnvironmentClinical research labs, pharmaceutical settingsHospital labs, diagnostic labs
Industry UsagePharmaceuticals, clinical researchHealthcare, diagnostics

Gclp professionals focus on ensuring compliance with Good Clinical Laboratory Practice in research settings, while Clinical Laboratory Scientists perform diagnostic testing in healthcare labs. Both roles require laboratory skills but differ in industry focus and certifications.

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Gclp jobs near you
Infographic showing various Gclp job openings in the United States as of August 2026, with employment types broken down into 95% Full Time, 1% Part Time, and 4% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $50,049 per year, or $24.1 per hour.

Associate Director, Biosample Operations

Denali Therapeutics

South San Francisco, CA • On-site

$171K - $223K/yr

Full-time

Medical, Retirement

Posted 27 days ago

Job description

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This role safeguards the quality and continuity of biosample data that underpins clinical development and regulatory submissions across Phase I-IV trials. It exists to translate biospecimen strategy into consistent, compliant execution across specialty laboratory vendors, protecting both data integrity and program timelines. Leading vendor oversight and cross-functional alignment, this position ensures inspection readiness and enables confident, data-driven development decisions across the clinical portfolio.
Key Accountabilities/Core Job Responsibilities:
  • Lead vendor identification, qualification, and oversight of bioanalytical and clinical diagnostic laboratories supporting Phase I-IV clinical trials, ensuring quality, compliance, and timeline adherence.
  • Direct biosample operational strategy and standards, driving improvements in efficiency, scalability, and vendor performance.
  • Partner with Quality and Regulatory teams to ensure laboratory processes and documentation comply with GCLP, GCP, and applicable IVD regulations.
  • Align biomarker, PK, and immunogenicity testing strategies with cross-functional development teams.
  • Manage laboratory audits, inspections, and CAPA resolution to maintain continuous inspection readiness.
  • Serve as Biosample Operations Program Lead, directing biospecimen strategy across assigned clinical development programs.
  • Communicate laboratory operational status, risks, and escalations to study teams, functional leadership, and external partners.
  • Oversee contract and budget performance for specialty laboratory vendors.
  • Supervise and develop Biosample Operations clinical study leads, setting annual goals and providing ongoing performance feedback.

Qualifications/Skills Required:
  • Bachelor's degree in Biology, Biochemistry, Analytical Chemistry, Medical Technology, or a related field.
  • Typically 9+ years of experience in Clinical Operations, Biosample Operations, Translational Sciences, or Bioanalytical Sciences.
  • Typically 5+ years of experience managing direct reports.
  • Demonstrated experience overseeing bioanalytical or clinical diagnostic laboratory vendors, including issue identification and resolution.
  • Working knowledge of FDA, ICH/GCP, GDPR, IVDR, and GCLP regulations.

Preferred:
  • Experience developing tools or systems that improve biosample operational workflows.

Salary Range: $171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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