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
- Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable adjustments considered where appropriate
Skills Required
- Bachelor's degree
- Degree in a health or science field
- Prior experience in clinical research, data management, or regulatory affairs
- At least two years experience monitoring and managing clinical research projects
- Proficiency in Microsoft Office
- Experience with Clinical Trial Management Systems (CTMS) and Electronic Trial Master File (eTMF)
- Ability and willingness to travel up to 20%
- Strong organizational skills and attention to detail
- Excellent written and oral communication skills
- Leadership and management skills
- Ability to remain stationary for extended periods
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.






