Clinical Trial Project Manager

WEP Clinical; Morrisville (NC); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401K plan with company match

Paid vacation and holidays

Parental leave

Job summary

WEP Clinical in Morrisville, NC is seeking a Clinical Project Manager to lead the setup, execution, and close-out of clinical trials, ensuring patient safety, data integrity, and regulatory compliance.

The role requires 5+ years in clinical trial project management, a BA/BS in health or science, and strong cross-functional leadership, communication, and problem-solving skills. Travel may be required, and the position offers a comprehensive benefits package.

Qualifications

• Bachelor’s degree in health or science field.
• Minimum 5 years’ experience in a Project Manager role within clinical trials or clinical research.
• Demonstrated experience managing clinical trials from initiation through close-out.
• Strong knowledge of ICH GCP guidelines and clinical trial processes.
• Proven ability to lead cross-functional teams and manage multiple priorities.
• Strong organizational, problem-solving, and decision-making skills.
• Effective verbal and written communication skills.
• Proficiency in Microsoft Office tools.
• Ability and willingness to travel as required for business needs.

Responsibilities

• Lead the setup, execution, and close-out of clinical trials in compliance with SOPs, GCP/ICH guidelines, and regulatory requirements.
• Provide day-to-day accountability for the operational delivery of assigned clinical trials.
• Develop and maintain study manuals, operational project plans, timelines, and key performance metrics.
• Ensure proper setup, maintenance, and close-out of eTMF and CTMS systems.
• Serve as project team lead and primary point of contact for internal and external stakeholders.
• Provide oversight and coordination of cross-functional deliverables including monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing.
• Ensure internal and external teams are appropriately trained on study protocols and operational requirements.
• Act as the primary client contact for clinical trial operations, deliverables, and issue resolution.
• Lead internal and external meetings, ensuring alignment on project status, risks, and timelines.
• Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle.
• Implement mitigation strategies and corrective actions where required.
• Oversee submissions to IRB/ECs and review informed consent forms as required.
• Ensure compliance with regulatory requirements and internal quality standards.
• Collaborate with Quality Assurance to support audits, CAPAs, and investigations as appropriate.
• Manage project budgets, scope, and financial performance.
• Oversee vendor performance and deliverables, including review and approval of invoices.
• Review site payments and ensure alignment with Clinical Trial Agreements.
• Maintain accurate and complete trial documentation within internal systems (e.g., SharePoint).
• Ensure all trial records meet quality and compliance standards.

Skills

Project management

Cross-functional leadership

Regulatory awareness

Problem-solving

Communication skills

Education

Bachelor's Degree in health or science

Tools

Microsoft Office

Job description

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 Clinical Project Manager at WEP Clinical is responsible for the setup, implementation, and management of clinical trials, ensuring patient safety, data integrity, and high-quality delivery in compliance with applicable regulations.

This role provides leadership across cross-functional teams, manages client relationships, and is accountable for delivering clinical trials on time, within scope, and within budget.

The Ideal Candidate

• Adaptable
• Detail-oriented
• Collaborative
• Solutions-focused

What You'll Do

The level of appointment (e.g., Project Manager II or Senior Project Manager) will be determined based on the candidate’s experience, skills, and demonstrated capabilities during the interview process.

Principal Duties and Responsibilities

• Lead the setup, execution, and close-out of clinical trials in compliance with WEP Clinical SOPs, GCP/ICH guidelines, and regulatory requirements.
• Provide day-to-day accountability for the operational delivery of assigned clinical trials.
• Develop and maintain study manuals, operational project plans, timelines, and key performance metrics.
• Ensure proper setup, maintenance, and close-out of eTMF and CTMS systems.

Leadership & Cross-Functional Oversight

• Serve as project team lead and primary point of contact for internal and external stakeholders.
• Provide oversight and coordination of cross-functional deliverables including monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing.
• Ensure internal and external teams are appropriately trained on study protocols and operational requirements.

Client & Stakeholder Management

• Act as the primary client contact for clinical trial operations, deliverables, and issue resolution.
• Lead internal and external meetings, ensuring alignment on project status, risks, and timelines.

Risk & Issue Management

• Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle.
• Implement mitigation strategies and corrective actions where required.

Regulatory & Compliance

• Oversee submissions to IRB/ECs and review informed consent forms as required.
• Ensure compliance with regulatory requirements and internal quality standards.
• Collaborate with Quality Assurance to support audits, CAPAs, and investigations as appropriate.

Financial & Vendor Management

• Manage project budgets, scope, and financial performance.
• Oversee vendor performance and deliverables, including review and approval of invoices.
• Review site payments and ensure alignment with Clinical Trial Agreements.

Documentation & Systems

• Maintain accurate and complete trial documentation within internal systems (e.g., SharePoint).
• Ensure all trial records meet quality and compliance standards.

What You'll Need

• Bachelor’s Degree (health or science field preferred)
• Minimum 5 years’ experience in a Project Manager role within clinical trials or clinical research
• Demonstrated experience managing clinical trials from initiation through close-out
• Strong working knowledge of ICH GCP guidelines and clinical trial processes
• Proven ability to lead cross-functional teams and manage multiple priorities
• Strong organizational, problem-solving, and decision-making skills
• Effective verbal and written communication skills
• Proficiency in Microsoft Office tools
• Ability and willingness to travel as required for business needs

Additional Notes

• This role may be filled at different levels depending on experience and demonstrated capability.
• Responsibilities may expand in scope with increased seniority and complexity of assigned projects.

Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.

What We Offer

• Medical, dental, and vision insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

What Sets Us Apart

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

We're Committed to Our Team

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check outour LinkedIn Life Page to learn more about our team events and all we do to support our employees.

How We Work at WEP Clinical

At WEP Clinical, we look for individualswho are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services Include

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization

Data Privacy Notice

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

Privacy Policy: https://www.wepclinical.com/privacy-policy/

Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/

Safety Notice

We will never communicate with you via Microsoft Teams or text message.

We will never ask for your bank account information at any stage of recruitment.

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