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Project Management Opportunities at Parexel

In a Project Leader job at Parexel, you’ll help deliver sponsor projects and programs on time and on budget. You’ll develop and implement detailed project plans that reflect core objectives, prevent risk, and deliver results in compliance with SOPs, ICH, GCP and other guidelines. Help support the development of advances and treatments that are changing lives. Explore Project Leader jobs at Parexel.

Project Management Assistant

Job ID 60698BR Baltimore, Maryland
Project Management
-Coordinate with Project Manager or Clinical Lead to complete IRB/EC
submissions and maintain IRB correspondence according to IRB guidelines and
regulations.
-Serve as primary contact and liaison for IRB/EC; inform team members of any new
information or modifications which may affect specific responsibilities of team
members; report to line managers any anticipated needs or performance issues.
• Support Project Manager in organizing and follow-up of meetings (i.e. technical
meetings, internal meetings).
• Support communications among team members with timely and accurate distribution
of materials and by maintaining Project Management files and meeting minutes of
key meetings as required.
• Assist in preparation and QC of documents as requested by PM.
• Prepare project timelines and team contact lists as requested.
• Manage and coordinate client survey process.
• Manage and coordinate clinical trial insurance process.
-Manage and coordinate archival process.
-Serve as backup point of contact for PM or Clinical Lead communications

Administrative
• Prepares and maintains regulatory documents including but not limited to the FDA
Form 1572, financial disclosures and protocol review forms for all protocols,
• Creation and QC of IRB/EC submission forms including but not limited to
preparation of continuing reviews and IRB closeout report.
• Request documents from the IRB as required.
• Ownership of the internal and external regulatory files/Investigator Site Files,
including creation, maintenance, and QC processes.
• Maintaining up to date laboratory documents such as CAP, CLIA, and lab director
CVs and request updated certificates as required (including filing the updated reports
in the Regulatory files).
• Support PM team in the creation, maintenance, and finalization of project documents
according to PAREXEL SOPs and departmental policies
• Compose professional business correspondence for the PM team, clients and outside
vendors (including but not limited to check requests, reports, memos, meeting
minutes, and letters).
• Prompt preparation and filing of invoices.
• Ordering through ARIBA including ordering and maintaining office supplies as
necessary.
• Coordinate ordering/shipping/ receiving of special equipment and supplies as
necessary for projects.
• Request Help Desk tickets as requested by the PM.
• Coordinate all incoming and outgoing communications (including daily checks of
the fax machine and FedEx/UPS boxes) for the project and develop appropriate
systems (i.e. follow-up systems, tracking).
• Schedule and prepare for monitoring and sponsor visits in advance (including QC of
Regulatory binder prior to each monitoring visit and assisting monitor during the
monitoring visit).
• Maintain monitoring rooms including daily checks at the end of the day to ensure all
binders and documents are returned to the PM or coordinators.
• Reserve monitoring rooms and conference rooms as requested by the PM; maintain
monitoring room and conference room calendar.
• Creation, maintenance, and submission of study meal requests.
• Book travel and prepare expense reports as needed.
• Schedule teleconferences and meetings as requested.
• Order meals, taxi, etc. and prepare for internal and external visitors as needed.
• Monitor the front desk during am hours and as required for client visits/visitors.
• Copy assigned PM on all correspondence for a project.
• Maintain, track and archive documents within PM department and as required for the
unit.
• Support and coordinate contract review/signature process with the PAREXEL
contract team.
• Support other members of Project Management group as needed.
• Foster team environment by assisting other team members with questions and
sharing tools/ideas.
• Request clarification as needed on assigned tasks and provide frequent updates and
feedback.
Any other duties as assigned.

Qualifications

Skills:
• Comprehensive knowledge of relevant software: Microsoft Windows Operating System and the MS Office
Suite including Word, Excel, Outlook, and PowerPoint.
• Excellent oral and written communication skills.
• Highly organized with the ability to manage multiple conflicting deadlines and competing priorities.
• Ability to work in a fast paced environment with minimal supervision.
• Experience in dealing with confidential materials.
• Ability to liaise with senior management within PAREXEL.

Knowledge and Experience:
• 1-2 years in a similar administrative position or work experience in other clinical research roles preferred

Education:
• High school diploma or equivalent.
• College degree preferred

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.

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