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Senior Project Manager

2 months ago

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

Are you a seasoned Project Manager seeking a new and stimulating challenge? WEP Clinical invites you to join our dynamic team and take a pivotal role in orchestrating the setup, execution, and management of Expanded Access Programs (EAP) and Post Approval Named Patient Programs (PA-NPP). We thrive on innovative thinking and empower our team to drive impactful solutions for both clients and patients. If you're passionate about advancing patient outcomes and making waves in clinical research, this is the place for you.


Who We're Looking For:


  • Team Player
  • Adaptable
  • Detail Oriented
  • Problem Solver


What You'll Do:


  • Oversee and manage the set-up, execution, and close-out of regional and global projects in compliance with WEP Clinical SOPs and Policies.
  • Develop, maintain, and ensure compliance with project plans, including timelines and budgets, and track out-of-scope services in Change Orders.
  • Provide leadership, training, and operational oversight for the project team.
  • Build and maintain positive client relationships.
  • Identify, evaluate, monitor, and mitigate risks to project quality and communicate these risks to internal team members, upper management, and clients.
  • Participate in proposal meetings for potential clients and support Business Development with contracts.
  • Assist in developing, documenting, and updating internal WEP Clinical procedures and processes for consistency across programs.
  • Serve as a line manager for direct reports, including training, development, and performance reviews.
  • Audit the compilation and completion of the eTMF and CTMS, ensuring timely filing and data entry.
  • Maintain up-to-date knowledge of US, UK, and EU regulations as well as GXP/ICH Guidelines for EAP/PA-NPP and clinical research.


What You'll Need:


  • Bachelor's Degree (Health or Science field preferred).
  • 4+ years of project management or clinical research experience, preferably in a CRO setting.
  • 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, sick, and volunteer time
  • Paid maternity & paternity leave
  • Personal Development Allowance


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)

Open Label Extension Studies (OLE)

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.


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