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EAP Project Manager

4 months ago

Morrisville, United States WEP Clinical Full time
Job DescriptionJob DescriptionSalary:

 Exciting Opportunity: Clinical Project Manager (WEP Clinical)


Are you an experienced Clinical Project Manager looking for a new challenge? Join our dynamic team at WEP Clinical and play a vital role in the setup, execution, and management of Expanded Access Programs (EAP) and Post Approval Named Patient Programs (PA-NPP). Join us in our mission to improve patient outcomes and make a difference in the field of clinical research.


 Role Objectives:


As a Clinical Project Manager at WEP Clinical, you will take charge of developing, executing, and successfully concluding clinical research programs, focusing on EAPs and PA-NPPs. Your responsibilities will include overseeing the setup and close-out of electronic trial master files, clinical trial management systems, conducting audits, coordinating shipments, collaborating with cross-functional teams, and ensuring program deliverables are achieved on time and within budget.


The Ideal Candidate:


  • Team Player
  • Adaptable
  • Detail Oriented
  • Problem Solver


Principal Duties and Responsibilities:


  • Lead the planning, execution, and close-out of clinical research programs, including EAPs and PA-NPPs.
  • Manage setup and close-out of eTMF and CTMS, ensuring accurate data entry and maintenance.
  • Conduct routine audits of document storage systems and CTMS for compliance.
  • Oversee supply chain team activities for investigational product shipments.
  • Coordinate internal and external teleconferences and lead project-related discussions.
  • Develop and execute project plans for new EAP programs.
  • Provide protocol-related training to investigators and site staff.
  • Supervise and mentor project team members.
  • Review and approve client invoices and payments.
  • Serve as a central point of contact for clients and vendors.
  • Collaborate with Quality Assurance for investigations, CAPAs, and audits.


 Qualifications:


  • Bachelor's Degree (Health or Science field preferred).
  • 4+ years of project management or clinical research experience.
  • Minimum of 2 years' experience in monitoring and managing clinical research projects.
  • Proficiency in Microsoft Office.
  • Ability to travel up to 20% of the time.
  • Strong organizational skills and attention to detail.
  • Excellent verbal and written communication skills.
  • Demonstrated leadership and management abilities.


What We Offer:


  • Medical, dental, and vision insurance
  • Short-term disability insurance
  • Life insurance
  • Voluntary Long-term disability insurance
  • 401K safe harbor plan and company match
  • Paid vacation, holiday, and sick time
  • Paid maternity & paternity leave


✨ 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 a decade of experience distributing products worldwide to treat unmet patient needs.


We're Committed to Our Team:

WEP has many initiatives in place to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, 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.