Project Manager - Early Phase at Parexel

Glendale, California, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Aug, 26

Salary

138000.0

Posted On

18 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Negotiation, Influence, Decision-making, Problem-solving, Root Cause Analysis, Interpersonal Communication, Time Management, Organizational Skills, Strategic Thinking, Financial Management, Project Planning, Risk Management, Sponsor Liaison, Clinical Operations

Industry

Pharmaceutical Manufacturing

Description

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. Home Based (Preference for CA, CO, or TX locations) The Project Manager for Early Phase (EP) leads Parexel and Sponsor teams by leveraging clinical research experience and project management skills to develop tailored solutions for sponsors. This role requires a deep understanding of business, knowledge, experience, and flexibility to make informed and effective decisions independently. The Project Manager ensures operational excellence and successful execution of clinical operations and logistical strategies for EP clinical trials or programs. They are accountable for the successful delivery of projects/programs on time, on budget, and to the highest quality, compliant with ICH, GCP, and other applicable regulations. The Project Manager also manages the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices, while ensuring compliance with relevant SOPs, contract terms, system requirements, and metrics. Key Accountabilities: Communication and Sponsor Liaison Own the sponsor relationship and manage sponsor communication. Serve as the central point of contact and escalation for functional teams. Proactively communicate project progress, risks, and solutions to sponsors and internal teams. Lead regular meetings with sponsors and project teams to ensure objectives are met. Pre-award Activities Review relevant materials and attend strategy meetings. Prepare for Bid Defense and develop project management strategies. Attend Bid Defense and handover meetings. Project Planning & Initiation Manage study start-up activities and ensure best practices are implemented. Oversee site selection strategy and review project contracts and budgets. Set up project teams and systems, and manage IRB/EC and RA approval processes. Lead internal and sponsor kick-off meetings and ensure team understanding of project scope and expectations. Project Implementation, Control & Evaluation Lead projects to completion within budget and schedule, ensuring contract specifications are met. Provide performance feedback and ensure project tracking using CTMS. Monitor study timelines, recruitment, retention, and data cleaning. Prepare for audits/inspections and manage project budgets. Project Close-out Oversee administrative closeout procedures and ensure project documentation is archived. Lead end-of-study meetings to document lessons learned. Risk Management Identify potential project risks and implement contingency plans. Mitigate risks and keep clients informed throughout the study life cycle. Administrative Tasks Contribute to SOP development and provide oversight and training to Associate PMs and Project Assistants. Skills: Leadership skills to lead virtual teams across locations and cultures. Negotiation and influence skills to achieve results. Decision-making skills in ambiguous situations. Problem-solving and root cause analysis skills. Excellent interpersonal, oral, and written communication skills. Time management and organizational skills. Strategic thinking and financial management skills. Knowledge and Experience: 2 years of Project Management experience with Parexel or 3 to 5 years in related fields. Experience as a Functional Team Leader or in coordinating clinical trials. Knowledge of ICH-GCP and pharmaceutical industry regulations. Proficiency in MS-Office products. Education: Bachelor’s degree in a science-related field or equivalent work experience. Advanced degree preferred. Additional business degree or PMP certification is an advantage. Scientific/Medical/Pharmacology background is an advantage. Ready to Make an Impact? Apply today to join a high-performing Project Management Team where your expertise will shape the outcome of Clinical Research. Base Pay Range: $125 - $138K Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

Leads Early Phase clinical trials by managing sponsor relationships and ensuring projects are delivered on time, within budget, and in compliance with regulations. Oversees the entire project lifecycle from pre-award activities and study start-up to implementation and close-out.