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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 Assistant

Job ID 59947BR Baltimore, Maryland
•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 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
•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).
•Reserve monitoring rooms and conference rooms as requested by the PM; maintain monitoring room and conference room calendar.
•Schedule teleconferences and meetings as requested.
•Copy assigned PM on all correspondence for a project.
•Maintain, track and archive documents within PM department and as required for the unit.
•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:
•At least 2-3 years in a similar administrative position or work experience in clinical research role such as a study technician or entry level coordinator

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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