WEP Clinical
NPP & Market Access Project Management
ProjectManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Project Manager at WEP Clinical. Skills: Named Patient Programs, Clinical research programs, Project management. Manage development of clinical research programs. Manage execution of clinical research programs”
What You'll Achieve.
On-time performance; On-budget performance; Deliverables according to CSAs
Industry & Context.
Problem solving
Up to 20% travel
What They're Looking For.
Must Have
2 years experience monitoring clinical research projects, Computer literacy, Proficiency in Microsoft Office, Ability to travel up to 20%, Organizational skills, Attention to detail, Excellent written communication skills, Excellent oral communication skills, Leadership skills, Management skills
Nice to Have
Health or science field degree, Prior experience in clinical research, Prior experience in data management, Prior experience in regulatory affairs
What You'll Do.
Manage development of clinical research programs
Manage execution of clinical research programs
Manage close-out of clinical research programs
Execute project plans for PA-NPP programs
Serve as central point of contact for client
Serve as central point of contact for vendors
Assist drug safety team
Maintain document storage systems
Maintain program data
Maintain patient data
Oversee supply chain team
Coordinate shipment dispatch
Dispatch investigational products
Lead project Kick Off Meetings
Lead weekly check-ins
Liaise with Quality Assurance team
Initiate investigations
Conduct investigations
Conduct routine audits
Submit central IRB applications
Perform central IRB applications
Oversee development of project documentation
Oversee development of CRFs
Ensure documentation updates
Supervise project team members
Train project team members
Mentor project team members
Provide protocol-related training
Oversee PA-NPP program budget
Oversee PA-NPP scope of work
Ensure on-time performance
Ensure on-budget performance
Ensure deliverables according to CSAs
How You'll Work.
Team & Collaboration
Project team members; Quality Assurance team; Supply chain team; Drug safety team; Internal teams; External teams
Communication Scope
Written communication; Oral communication; Client communication; Vendor communication; Protocol training
Process & Methodology
Project planning, Project execution, Project close-out, Budget management, Scope management
Full Job Description
## Description Do you want to be a part of a team that gives hope to patients with rare and life-threatening diseases? Are you looking for career growth, challenges, or a more motivating role? At WEP Clinical, our business is growing, and the career opportunities are endless. Our Project Managers’ help patients get early access to medicine every day. We challenge our team to bring thought-provoking ideas to the table. Join us and see the impact you can make! Role Objectives: The WEP Clinical Project Manager is responsible for the setup, implementation, and management of individual Post Approval Named Patient Programs (PA-NPP), including funded access schemes. ## The Ideal Candidate Team Player Adaptable Detail Oriented Problem Solver ## What You'll Do Manage the development, execution, and close-out of clinical research programs, including expanded access, managed access, and compassionate use programs. Execute project plans for new PA-NPP programs, serve as the central point of contact for the PA-NPP client and 3rd party vendors, and assist the drug safety team per the project-specific safety management plan. Setup & close-out of the Clinical Trial Management System (CTMS), and the Electronic Trial Master File (eTMF), prepare study files based on project scope including maintenance of internal or external document storage systems and maintain program, site, and patient-level data into the CTMS. Senior oversight of the supply chain team to coordinate and dispatch shipments of investigational products. Lead internal and external teleconferences, project Kick Off Meetings, and weekly check-ins with project team members. Liaise with the Quality Assurance team to initiate and conduct program-related investigations, CAPAs, and conduct routine audits as well as submit and perform central IRB applications. Oversee the development of project-level documentation and CRFs, ensuring updates are made as needed throughout the program. Supervise, train, and mentor internal ap
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