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Education/RequirementsAssociate degree or higher preferred 1-2 year relevant experience in pharmaceutical industry or CRO Experience supporting clinical trials preferred Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus Experience using electronic data capture (EDC) systems is a plus Financial management experience is a plus.Responsibilities: Support study feasibility activities and perform database/web searches for sites as neededWork closely with the Site....


Education/ExperienceBS in life sciences or related field At least 2 years experience in clinical researchKnowledge of FDA regulations Prior Study Start-Up experience preferredAdvanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plusPresentation Delivery ResponsibilitiesExecute study start-up for assigned protocols within company timelines by identifying clinical team needs, Oversee Site....

- Menlo Park, CA

Education and Qualifications - M.D. ; Specialization in Hematology/Blood Cancers. - Preferable five to seven years clinical or clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry. - Expertise in Phase I clinical oncology studies. Overview The Medical Director will collaborate with company management, design, plan and develop clinical evaluation research studies in hematology oncology. He / She will prepare, author and....


CMC and Bioanalytical Document Control Contract (Short Term) La Jolla, CA Responsibilities:Assess CMC and bioanalytical documents generated to date and implement archival and retrieval structure for electronic and/or paper documentsEnsure that all CMC and bioanalytical documentation required by regulatory authorities for Phase 2 initiation is availableCompile and organize executed Batch Records from CMOs into binders and in electronic format to ensure document completeness and securityOrganize

- Irvine, CA

Client is seeking a Head of Quality to ensure best practices are implemented and followed at this high-volume contract manufacturer. RequirementsDirector-level or higher position in Quality a high-volume manufacturingExperience managing large teams and indirect reportsManufacturing experience should include FDA-regulated products such as pharmaceuticals, over the counter drugs, or dietary supplements.Certification in QualityBachelor DegreeDutiesCreate and manage systems for high-volume....

- Menlo Park, CA

Qualifications - 12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff. - Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to the conduct of regulated clinical trials. - Comprehensive understanding of applicable clinical research regulations. Thorough knowledge of GCP, ICH guidelines and other

- San Diego, CA

Our client seeks someone to manage all clinical QA efforts, including the continuous improvement of compliant GCP Quality Systems to ensure that the company and outsourced third parties are inspection ready at all times. QualificationsBachelor’s Degree in Chemistry, Biology, or Life sciences/related10 years’ experience with Clinical Quality Systems in the drug, biopharmaceutical or medical device fields.2+ years prior auditing experience required.Experience in implementation and....


EDUCATION/EXPERIENCE: - 1+ years of relevant experience in pharmaceutical industry - Science degree in medical or health-related field - Clinical Trial Support/Clinical Study experience - Work effectively in a team/matrix environment - Handle conflict management and resolution RESPONSIBILITIES: - Ensuring that clinical studies are run on time and budget - Ensure compliance with regulatory guidelines - Management of clinical trial documentaiton - Tracking of various clinical trail resources


Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials Requirements Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.Ability to travel as required (up to 25%).12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff.Industry experience within pharmaceutical....


JOB SUMMARY: Reporting to the Director, Quality, this position will plan and ensure the implementation of the ISO 14971, IEC 62366 and 21 CFR 820 standards to ensure safe products exceed customer and market requirements. This individual will need to work closely with manufacturing sites, support audits, work with new product development, as well as on-market teams in regard to change management and product life-cycle management. The Senior Manager, Risk Management will ensure product....


The Study Management Associate (also known as Clinical Trial Management Associate) assists the Sr. Clinical Trial Management Associate, Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies. In this role the associate will perform tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and....


Client is seeking a Regulatory Affairs Compliance Manager to ensure regulatory compliance is implemented and followed at this high-volume contract manufacturer. Requirements Manufacturing experience should include FDA-regulated products such as pharmaceuticals, over the counter drugs, or dietary supplements. Bachelor Degree Duties - Manage coordinate and prioritize the daily activity of the department and related staff - Interact with various departments as needed on regulatory compliance....

- Seattle, WA

Position is located in Seattle, relocation expenses covered. Client is seeking a Clinical Program Manager to plan and manage the overall execution of the assigned clinical program to meet necessary quality standards (including ICH GCP, local regulations), budget and timelines, including recommending operational strategies and/or decisions. This person reports to the Director of Clinical Operations and manages the studies through their assigned Clinical Trial Managers. Requirements:University....

- Menlo Park, CA

Phase I company needs a Clinical Trial Manager/Clinical Project Manger to manage the day-to-day operations of the company’s cell-therapy clinical trials and associated projects. Company is open to W-2, contract and contract to hire. This position is onsite at the company HQ in Menlo Park, CA. Qualifications5+ years of experience in clinical research and/or clinical trial operations with a strong track record of successful trial initiation and execution. Sponsor (industry) organization....

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