Clinical Ethicist jobs in Raleigh, NC

🌟 Exciting Opportunity: Senior Clinical Project Manager/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), Open-Label Extension Studies (OLE), and Post Approval Named Patient Programs (PA-NPP). We challenge our team to bring thought-provoking ideas to the table and to help define and drive solutions for clients and patients. Join us in our mission to improve patient outcomes and make a difference in the field of clinical research.

🔍 Role Objectives:

As a Senior Clinical Project Manager at WEP Clinical, you will take charge of developing, executing, and successfully concluding clinical research programs, including EAPs, PA-NPPs, and/or OLE studies 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:

• Manage the setup, execution, and close-out of the project including the budget and scope of work
• Provide accountability for day-to-day operations of the project
• Develop and maintain operational project plans, including detailed timelines
• Serve as primary contact with Client
• Provide cross-functional oversight of internal project team members and deliverables, including monitoring activities, site management, data management, pharmacovigilance, medical writing, regulatory activities, project-specific training, shipment coordination, and other project-specific requirements
• Engage all project stakeholders to identify, assess, mitigate, and manage risk
• Proactively anticipate and identify issues; implement solutions, propose corrective actions
• Setup, maintain, and close out the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS)
• Coordinate and lead internal and external teleconferences and meetings
• Manage vendor deliverables and quality, review vendor invoices
• Provide protocol-related training to site staff

🎓 Qualifications:

• 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.