Project Manager - Early Phase Clinical Operations

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.

This role is remote with a 25% travel requirement to Baltimore, MD (around 10 visits a year)

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:

• Problem solving and critical thinking
• 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
• 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

Your Profile:

• 2+ years of experience as Project Manager for a Clinical Research Organization or sponsor 
• Early Phase experience is required (Phase I) - ideally 2+ years
• Experience Managing multiple and varied tasks with enthusiasm, with attention to detail, strong customer focus
• Working with Data Management, Biostatistics, and Medical Writing teams is highly preferred
• 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
• Bachelor’s degree 

Benefits: Medical, dental, and vision insurance. Competitive 401K plan. Routine time off. These are just a few of the benefits this position is eligible for. All benefits are effective day one of employment.

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.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.