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Clinical Study Team Assistant II- FSP

Parexel International Corporation

USA - Any Region - Home Based

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

In this role you will partner with the Clinical Study Team Lead to ensure delivery of clinical operational components in Modules 1, 2 and 5 of eCTD (electronic Common Technical Document)- meeting timelines and quality requirements

• Maintain, verify, process, and makes updates to client systems (including Registry), spreadsheets /documents as needed.

• Provide support for filing/uploading documents to the appropriate repository, Trial Master File , Global Document Management System (GDMS), etc.

• Generate reports from client systems as directed to support completion of and tracking of submission deliverables

• Generate Master Investigator Lists

• Manage Vendor Lists

• Manage the QC of these lists against documents in the TMF

• Ensure organization and maintenance of shared spaces (SharePoint, etc.) for the submissions teams

• Set up submission space, including folder structure as directed, in shared space

• File documents to shared space as requested

• Review shared space to ensure others are updating tracking and filing as requested by the team

• Maintain tracking of documentation for the module 1, 2 and 5 components supporting the work of the CSTL.

• Maintain GDMS tracker for submission components and locate components in GDMS

• Support tracking of submission narratives and components of narratives

• Support follow-up of CRF generation for NDA submissions

• Support Submission Quality Plan components

• Support CSTL to drive endgame inspection readiness

• Follow up with teams to support financial disclosure and ensure completion

• Drive the due diligence process with for studies included in the submission

• Generate draft bias statements for the studies included in the submissions

• Support submission meeting planning and organization as directed to ensure regulatory requirements are met, and planned.

• Organize meeting rooms, teleconference information and equipment, meals, site access for external colleagues, etc.

• Working with CSTL, use submission timeline to plan appropriate meetings and reminders for submission team

• Act as central point of contact for submissions related tasks as needed

• Independently manage conflicting priorities to ensure excellent support to overall submission team; this requires negotiating with customers and/or other team member

• Identify and implement process improvements (e.g. lessons learned, effectiveness through efficiency, and systems audits) for inspection readiness, TMF compliance, etc.

• Support review and QC of submission documents as directed which may include review and comparison of documents in TMF, GDMS and/or other archival systems QualificationsPREFERRED QUALIFICATIONS

• Science background

• Experienced with clinical trial applications

• Effective verbal and written communication skills

• Ability to work independently but also as part of a larger team

• Ability to multitask and manage multiple competing priorities

• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality

• Strong knowledge of drug development SOPs, ICH/GCP requirements, clinical trials, medical terminology

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

• Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems

EEO DisclaimerParexel 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.

Job posted: 2021-09-24

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