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 applicable project team members, and provide protocol‑related training to PA‑NPP investigators and site staff.
- Oversee the PA‑NPP program budget and scope of work to ensure on‑time, on‑budget performance and deliverables according to Clinical Study Agreements.
What You’ll Need:
- Bachelor’s Degree (In a health or science field preferred)
- Prior experience in clinical research, data management, or regulatory affairs, with at least two (2) years of experience in the monitoring and management of clinical research projects is a plus
- Computer literacy and proficiency in Microsoft Office
- Ability and willingness to travel up to 20% of the time
- Strong organizational skills and attention to detail
- Excellent written and oral communication skills
- Leadership and management skills
What We Offer:
- Group Private Medical Insurance
- Group General Life Assurance
- Group Critical Illness and Group Income Protection
- Salary sacrifice pension scheme
- Enhanced maternity & paternity pay
- Educational Assistance allowance
- Paid volunteering day
WEP Clinical is an equal‑opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
