Project Manager - Early Phase Clinical Trials

Parexel is looking for a Project Manager to join our Baltimore, MD Early Phase Clinical Unit! Project Managers lead the Parexel and sponsor teams by combining clinical research experience and project management skills with insight into sponsor pressures and an ability to develop the right solution for each. This requires in-depth business understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. By providing overall leadership of EP clinical trials, the PM ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy.

Your Activities: 

Owning the sponsor relationship and is responsible for sponsor communication

Providing a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical and pharmacovigilance)

Maintaining a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner

Leading team meetings on a regular basis with project team to ensure project objectives are met

Ensuring the on-going communication to team members of the scope of work, timeline and project goals, technical information, and input from sponsor throughout the project including significant changes in resourcing, scope of work and timelines

Leading regular meetings/calls with sponsor to ensure they are fully informed of project progress, proactive decisions / solutions and how the project objectives are being achieved

Reviewing relevant materials (e.g. request for proposal, proposal, etc.)

Preparing for Bid Defense

Preparing monitoring and site management strategy

Managing study start up activities

Initiating the project following review of Lessons Learned to ensure current Best Practices are implemented

Defining, planning, and providing oversight of site selection strategy

Reviewing the applicable project contract/exhibit and provide comments as appropriate

Reviewing initial budget to provide feedback

Managing the set-up of the project team, overseeing request for resource, reviewing proposed team members for suitability, and managing any project team changes throughout the duration of the project

Initiating and/or managing IRB/EC and RA (when applicable) approval process with relevant team members

Organizing and leading the team internal kick-off meeting

Organizing and lead Sponsor Initiation Meeting by establishing expectations for project delivery, communication, and sponsor specific metrics, etc.

Overseeing set up and management of investigator payment• Supporting enrollment team with patient recruitment plan and retention plan

Coordinating and ensuring completion of process for study insurance

Working with the Project Assistant to set up project-specific training as needed for team members

Ensuring the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations

Coordinating monitors and vendors according to the monitoring plan/contractual obligations (as applicable)

Preparing, participating in, and following up on audits/inspections

Managing the project budget including providing input into revenue recognition, milestone payments and monthly pass-through invoices.

Other duties as assigned

Your Skills:

Ability to Lead a virtual team across locations and cultures

Ability to negotiate and influence with diplomacy in order to achieve results

Strong decision-making skills

Problem solving and critical thinking

Effective time management in order to meet daily metrics or team objectives

Excellent interpersonal, oral and written communication

Self-starter and independent learning ability

Strong presentation skills

Ability to work independently and in a team environment

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Your Profile:

Bachelor’s degree in a science related field

3+ years of experience as a lead Project Manager in early phase for a Clinical Research Organization

Experience Managing multiple and varied tasks with enthusiasm, with attention to detail, strong customer focus

In-depth understanding and experience in the clinical trial process

Knowledge of guidelines, ICH-GCP and other applicable local and international pharmaceutical industry regulations

Solid computer and internet skills including knowledge of MS-Office products such as Excel, Word, PowerPoint, and Project

​Please note: this position has a 25% travel requirement to Baltimore, MD

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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