Project Manager - Early Phase

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.

An exciting opportunity for a Project Manager (PM) to joining the project management team at our Early Phase (EP) Unit in Harrow! In this role as a PM, you will lead the Parexel and Sponsor teams by combining a depth of clinical research experience and project management skills with insight into sponsor pressures and an ability to develop the right solution for each sponsor.

We are looking for an experienced Project Manager who can develop tailored solutions for sponsors. The role involves ensuring operational excellence and successful execution of clinical trials, delivering projects on time, within budget, and to the highest quality standards.

This role will be either full time onsite in our Unit in Harrow, London, or we can consider a hybrid model where the successful individual attends the office approx. 2 days per week.

Key Accountabilities:

• Provides overall leadership of Early Phase clinical trials or programs.

• Owns the sponsor relationship, provides a central point of study contact, and ensures proactive communication with sponsors and internal groups

• Ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy.

• Manages study start-up activities, defines and plans site selection strategy, manage submission,  reviews project contracts and budgets, and sets up project team and vendors

• Identifies potential project risks, implements contingency plans, and keeps clients informed about risks and contingencies

• Leads administrative closeout procedures, ensures project documentation is archived, and conducts end-of-study meetings to document lessons learned

• Accountable for the financial aspects of project(s) including input into revenue recognition, milestone payments, and monthly pass-through invoices.

• Understands and ensures compliance with SOPs, contract terms, system requirements and metrics.

• Oversees PM Assistants to assure development of the project plan, team lists, and maintenance of central files /regulatory files.

Knowledge/Skills:

• An experienced Project Manager/Associate Project Manager or equivalent experience or related work experience in project management or related fields

• Experience as a Functional Team Leader in clinical/data management/logistics functions or proven experience in coordinating clinical trials

• Excellent presentation and speaking skills (business development experience desirable)

• Budget/Contract experience desirable

• In depth knowledge of guidelines, ICH-GCP and other applicable local and international pharmaceutical industry regulations

• Good working knowledge of MS-Office products such as Excel, Word, PowerPoint, and Project

Education:

• Bachelor’s degree in a science related field or a wealth of related work experience as a clinical research project manager or BA degree with work related experience as a clinical research project manager.