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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

FSP - Clinical Project Manager

Job ID 78308BR USA - Any Region - Home Based
About Parexel FSP
We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.


Position Purpose: The study is a complex platform study, capable of testing multiple investigational products simultaneously. It is an adaptive design spanning traditional phase 2 and phase 3 of clinical development. It is being conducted under the auspices of the NIH, U.S. Government COVID Response Operation and the AIDS Clinical Trial Group. It will enroll patients in the United States and in other areas around the world impacted by the COVID19 pandemic.

The Senior Clinical Project Manager (CPM) is accountable for the operational delivery of the Trial. They are a senior accountable leader who will manage CRO performance as well as managing risks to delivery. They will lead a matrixed team of other clinical research professionals to generate this important data in a timely fashion.

Key Responsibilities:
  1. Create an overall operational plan for the study, including timeline, key milestones, resources needed and budget.
  2. Assess the operational feasibility and resource considerations of new entrants to the trial.
  3. Working through established contract resource organizations and with the sponsor and networks:
    1. Create a global site/country strategy Oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment
    2. Oversee site activation including, the provision of investigational product, non-IP clinical supplies and laboratory materials; the completion of required regulatory documentation and the granting of needed systems access.
    3. Coordinate efforts to recruit participants into the trial including global trial and site specific recruitment plans, media and outreach programs and vendor programs.
    4. Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed.
    5. Oversee the executions of the data management plan. Ensure that queries are resolved and database closure occurs on time.
    6. Oversee various reporting requirements to industry partners, leadership and other stakeholder groups
    7. Oversee the study close-out plan.
  4. Create and oversee the execution of a study risk management plan. Proactively resolve risks to operational delivery.
  5. Lead team meetings. Support meeting documentation and follow-up action items.
  6. Facilitate reporting of study status to key stakeholders in NIH, USG and ACTG

Qualifications

Education and Experience
  1. B.A. , B.S. or higher. Education in the biological sciences preferred.
  2. Significant relevant clinical research experience
  3. At least 5 years’ experience in clinical project management, including documented experience in leading multi-national studies and working through contract research organizations. Experience with platform studies is desirable.
  4. At least 3 years’ experience leading teams. Project management experience is preferred.

Required Behaviors and Competencies:
  • Inspirational leadership
  • Stakeholder management
  • Creative problem solver
  • Matrixed team management


This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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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.

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