Project Manager - Early Phase

Parexel International; Harrow; On-site; GBP 65,000 - 90,000; Full time

Job summary

Parexel International in Harrow invites an experienced Project Manager to lead Early Phase clinical trials, partnering with sponsor teams to deliver on time, on budget and to high quality standards. This role combines clinical research know-how with project leadership.

The position offers hybrid work with approx two days in the office; or full time onsite in Harrow. You will drive study startup, risk management, budgeting and senior stakeholder communication, ensuring operational excellence and

Qualifications

• An experienced Project Manager/Associate Project Manager or equivalent experience in project management.
• Experience as a Functional Team Leader in clinical/data management/logistics functions or coordinating clinical trials.
• Excellent presentation and speaking skills; budget/contract experience desirable.
• In depth knowledge of ICH-GCP and applicable regulations.
• Proficient in MS Office (Excel, Word, PowerPoint, Project).

Responsibilities

• Provides overall leadership of Early Phase clinical trials or programs.
• Owns the sponsor relationship and ensures proactive communication.
• Ensures operational excellence and successful execution of clinical operations and logistics.
• Manages study start-up activities, site selection, submissions, contracts, budgets, and team setup.
• Identifies risks, implements contingency plans, informs clients about risks.
• Leads closeout procedures, archives documentation, and records lessons learned.
• Accounts for financial aspects including revenue recognition and invoices.
• Ensures compliance with SOPs, terms, and system requirements.
• Oversees PM Assistants for project planning and regulatory files.

Skills

Project management

Clinical trials

Budgeting

Stakeholder management

ICH-GCP knowledge

MS Office

Presentation skills

Team leadership

Education

Bachelor's degree in science

Job description

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.