Senior Project Manager

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives: The WEP Clinical Senior Project Manager is responsible for the oversight and/or management of the setup, implementation, and management of Expanded Access Programs (EAP), Post Approval Named Patient Programs (PA-NPP), clinical trials including Open Label Extension (OLE) studies, and/or other clinical research projects. 

The Ideal Candidate:

• Team Player
• Adaptable
• Detail Oriented
• Problem Solver

What You'll Do:

• Oversee and/or manage the set-up, execution, and close-out regional and global projects in compliance with WEP Clinical SOPs and Policies.  
• Ensure all project plans including timelines and budgets are developed, maintained, and incompliance with the contract and all out of scope services are tracked and included in Change Order. 
• Responsible for project team’s leadership, training, and operational oversight. 
• Responsible for building and maintaining positive client relationships. 
• Responsible for identifying, evaluating, monitoring, and mitigating any factors or processes that may threaten the quality of the project (i.e., risk management), as well as communicating identified risks to internal team members, upper-level management, and clients, as appropriate.   
• Participate in proposal meetings for potential clients and support Business Development with contracts. 
• In conjunction with management, assists with developing, documenting, and updating internal WEP Clinical procedures and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms. 
• Serve as line manager for direct report(s)including responsible for training, development, and performance reviews. 
• Audit the compilation and completion of the eTMF and CTMS, ensuring all documentation and data are filed/entered in a timely manner. 
• Maintain current 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)
• 4-7 years of experience in project management or clinical research, or an equivalent combination of education, experience, and expertise
• Proficient in Microsoft Office, with experience using eTMF and CTMS systems
• Solid understanding of the clinical research process from Phase I through regulatory submission
• Strong verbal and written communication skills, with the ability to express complex ideas and engage with staff at all levels
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities
• Able to handle confidential information with discretion and reason independently in clinical settings
• Familiar with ICH GCP guidelines and able to set targets, track trends, and implement mitigation plans
• Willingness and ability to travel up to 20%

What We Offer:Medical, dental, and vision insurance, FSA, HSAVoluntary short-term and long-term disability insuranceVoluntary life insurance401K safe harbor plan and company matchPaid vacation, holiday, and sick timePaid 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 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:Access Programs Clinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket Access and Commercialization
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