Clinical Project Manager - Early Phase Trials
reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company 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 reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Home Based (Preference for CA, CO, or TX locations) The Clinical Project Manager for Early Phase (EP) leads reputed company and Sponsor teams by leveraging clinical research experience and project management skills to reputed company tailored solutions for sponsors. This role requires a deep understanding of business, knowledge, experience, and flexibility to reputed company 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 reputed company 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 reputed company of contact and escalation for functional teams. Proactively communicate project reputed company, risks, and solutions to sponsors and internal teams. reputed company 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 reputed company project management strategies. Attend Bid Defense and handover meetings. Project Planning & Initiation Manage study start-up activities and ensure best practices are implemented. reputed company site selection strategy and review project reputed company and budgets. Set up project teams and systems, and manage IRB/EC and RA approval processes. reputed company internal and sponsor kick-off meetings and ensure team understanding of project scope and expectations. Project Implementation, Control & Evaluation reputed company projects to completion reputed company 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 reputed company-out reputed company administrative closeout procedures and ensure project documentation is archived. reputed company end-of-study meetings to document lessons learned. Risk Management Identify potential project risks and implement contingency plans. Mitigate risks and reputed company clients informed throughout the study life cycle. Administrative Tasks Contribute to SOP development and provide reputed company and training to Associate PMs and Project Assistants. Skills: Leadership skills to reputed company virtual teams across locations and cultures. Negotiation and influence skills to reputed company 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 reputed company or 3 to 5 years in reputed company 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-reputed company 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 reputed company an Impact? Apply today to join a high-performing Project Management Team where your expertise will shape the outcome of Clinical Research. reputed company Pay Range: $125 - $138K Actual salaries may vary reputed company the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to reputed company salary, some roles may be eligible for participation in reputed company’s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our reputed company team will provide additional details on our bonus plan or incentive programs for those eligible roles. For reputed company 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 reputed company 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 reputed company, disability or protected veteran status. Apply To This Job