Project Manager - EAP

at  WEP Clinical

Job Title: Project Manager
Department: Project Management - Expanded Access Programs / Post - Approval Named Patient Programs
Company: WEP Clinical
Location: Hybrid/Onsite - Chiswick Tower, London, England
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!
WEP Clinical is a market leader in Expanded Access Programs (EAP) & Post-Approval Named Patient Programs. We are a team of experts with over 15 years of experience, having distributed medicines in over 120 countries worldwide. We pride ourselves on having a global reach while maintaining local knowledge.

As a Project Manager, you will play a vital role in getting medicines to patients who have exhausted all viable options. You will be responsible for the setup, implementation, and management of individual Expanded Access Programs. Some other duties include:

• Managing the development, execution, and close-out of clinical research programs, including expanded access, managed access, and compassionate use programs.
• Execute project plans for new EAP programs, serve as the central point of contact for the EAP 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 EAP investigators and site staff.
• Oversee the EAP program budget and scope of work to ensure on-time, on-budget performance and deliverables according to Clinical Study Agreements.

Qualifications

At WEP Clinical, we pride ourselves on the support and comprehensive trainings we offer our colleagues. In order to enable success, we look for candidates with:

• 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

At WEP Clinical, we value our employees and believe that they are our greatest asset. As a member of our team, you will have the opportunity to work on projects that make a meaningful difference in the lives of patients. We are committed to fostering a supportive and collaborative work environment, where employees encouraged to share their ideas and work together to achieve our mission in delivering treatment to patients. Additionally you will receive:

• Competitive salary and benefits package including comprehensive health insurance, discretionary annual bonuses, personal development allowance, pension schemes, summer hours, company socials and more!
• Opportunity to work in a small but dynamic team environment;
• Flexible working arrangements; including hybrid working from home and our UK headquarters in Chiswick Tower, London.

More About Us
WEP Clinical is a specialist services company that partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs. Our services include: Expanded Access Programs (EAPs), Named Patient Programs (NPPs), Clinical Trial Supplies (Comparator & Ancillaries), Wren Nursing (Clinical Trial Home Nursing & Clinical Education) and Hospital Supply of Unlicensed Medicines

• Managing the development, execution, and close-out of clinical research programs, including expanded access, managed access, and compassionate use programs.
• Execute project plans for new EAP programs, serve as the central point of contact for the EAP 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 EAP investigators and site staff.
• Oversee the EAP program budget and scope of work to ensure on-time, on-budget performance and deliverables according to Clinical Study Agreements