Project Manager II

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:

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.

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 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

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 sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Expanded Access Programs (EAPs)

Named Patient Programs (NPPs)

Clinical Trial Supplies (Comparator & Ancillaries)

Wren Nursing (Clinical Trial Home Nursing & Clinical Education)

Hospital Supply of Unlicensed Medicines

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

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.