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1060 Parexel International, LLC
California, CA | Full Time
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1060 Parexel International, LLC
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Early Phase Clinical Project Manager
$99k-125k (estimate)
Full Time 1 Month Ago
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1060 Parexel International, LLC is Hiring a Remote Early Phase Clinical Project Manager

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Join Parexel’s team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. Job Title: Project Manager (Early Phase) Job Introduction At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking a Project Manager (Early Phase) to join our team. As a Project Manager in early phase, you’ll be joining a fast-paced, collaborative environment that’s helping support the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. Who we’re looking for: We are looking for an analytical, detailed oriented, problem solver with proven experience leading and managing clinical trials with a passion for working in early phase. What you’ll do (including but not limited to): Lead a variety of early phase clinical trials located at one of Parexel Early Phase Units in the US Create informed and effective decisions independently Drive quality communication with sponsors and be their main point of contact Ensure the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy Make informed and effective decisions independently Accountable for the financial aspects of project(s) including input into revenue recognition, milestone payments, and monthly pass-through invoices Accountable for the successful delivery of projects/programs (on time, on budget, to the highest quality) compliant with ICH, GCP, and other applicable documents and regulations Understand and ensure compliance with SOPs, contract terms, system requirements and metrics Providing a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical and pharmacovigilance) Additional details: Project Management experience leading clinical trials from start up to close out (at least 2 years) Experience working on early phase trials preferably at the site level Experience as a Functional Team Leader in clinical/data management/logistics functions or proven experience in coordinating clinical trials In depth knowledge of guidelines, ICH-GCP and other applicable local and international pharmaceutical industry regulations Located in one of the following states: AZ, CA, CO, ID, MT, NM, NV, OR TX, WA, WY Why join us: Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Parexel US Benefits: Health, Vision & Dental Insurance Tuition Reimbursement Vacation/Holiday/Sick Time Flexible Spending & Health Savings Accounts 401(k) with Company match Pet Insurance Full list of benefits available here: https://www.parexel.com/us-benefits If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply! Parexel is dedicated to supporting, developing, and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers at Parexel. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Job Summary

JOB TYPE

Full Time

SALARY

$99k-125k (estimate)

POST DATE

03/10/2024

EXPIRATION DATE

05/08/2024

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