Project Manager - Early Phase

Parexel • Indianapolis, IN • 2h ago

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.

LI-REMOTE

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

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