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- Irvine, CA
new job!

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....

- Irvine, CA
new job!

Our client is looking for an engineer to join their Device Product Development group. The candidate will be responsible for test method development and validation; will be involved in investigation efforts, design feasibility and verification testing, and responsible for documentation of performed tests, analysis etc. Candidate in this position will be working with vendors (both manufacturing and development partners). The time is split between lab and desk, 50/50. The candidate may present....

- Irvine, CA
new job!

QUALIFICATIONS: Education: · Bachelors. degree; Advanced degree (e.g. Master, PharmD, PhD) preferred Experience: · Minimum of 5 years of pharmaceuticals/biotech experience · Minimum of 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials · Extensive experience in the operational and scientific/medical aspects of clinical development. · Critical thinking skills, and ability to....

- Irvine, CA
new job!

Our client needs a Contractor to work as Clinical Trial Associate. Contract is estimated for 12 months at their facility in Irvine, CA. Possibility for conversion to full-time after a year. We offer benefits including employer contribution to healthcare for this position. You must have authorization to work in the United States (sponsorship is not available). Requirements. Must Have! Associate degree or higher 1-2 year relevant experience in pharmaceutical industry or CRO Experience supporting


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 Sr ACTM assists the CTM or OSL in the operational execution of assigned clinical studies. Experience: Qualifications / Experience: - B.A/B.S. in science or health-related field - Four (4) years clinical research experience or related experience with a Bachelor’s Degree - Monitoring experience is preferred In addition to the essential skills, the incumbent must have the following: - Ability to handle and prioritize multiple tasks simultaneously, - Work effectively in a team/matrix....

- Irvine, CA
new job!

Qualifications: At least 3 years of experience in clinical research Prefer candidate with prior experience as Study Start-Up Specialist but not mandatory Description: I. POSITION SUMMARY: The Site Start-Up Specialist is responsible for executing study start-up for assigned protocols with the goal of meeting study start-up timelines. Monitor project plans to meet Site Initiation Readiness at the Investigator Meeting. Ensure the accuracy and quality of deliverables from clinical team and....

- Irvine, CA
new job!

This is a temp-to-hire situation expected to last 1 year. Qualifications - B.S. degree. - Minimum of 3 to 5 years of pharmaceuticals/biotech experience. - Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials. - Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model,....

- 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....

- 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....

- San Clemente, CA

Our client is about to begin enrolling the Phase III pivotal trials for their breakthrough drug/device combo. The client needs a senior QA consultant with pharma experience. Ideally can come into their offices in San Clemente 2-3 days per week for the next 3-6 months. Below is a wish list of experience/skills this person would have.Leadership experience with cGMP manufacturing quality function for all clinical stages of development (Phase 1-3) and commercial product Sr. Director level, at....


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

Clinical Trial Manager needed for phase I oncology studies. Duties include managing the study's budget and timeline, managing CROs and other vendors and managing CRAs. Qualifications and ExperienceBS or higher requiredMinimum of 5 (at least 2 years management) related experience in oncology /hematologyExperience in managing external CRO resources performing early phase clinical oncology trialsExceptional attention to detailProficiency with project management softwareAbility to travel for site....

- 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....

- 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....

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