Clinical Trial Project Manager

About WEP Clinical

Join the energetic team at WEP Clinical, where your efforts contribute to impactful solutions improving outcomes for clients and patients. The company encourages innovation and collaboration, offering a mission-driven environment dedicated to advancing clinical research and enhancing lives worldwide.

Role Summary

The Clinical Trial Project Manager is tasked with the comprehensive setup, execution, and management of clinical trials. This includes ensuring participant safety, maintaining data integrity, and delivering quality outcomes in strict adherence to regulatory and internal standards. The role demands leadership over cross-functional teams, management of client relations, and accountability for project delivery within agreed timelines, scope, and budgets.

Responsibilities

• Lead and oversee clinical trial initiation, execution, and closure following company SOPs, GCP/ICH guidelines, and regulatory mandates.
• Manage daily operations to guarantee successful trial delivery.
• Develop and update operational documentation such as study manuals, project plans, schedules, and KPIs.
• Maintain eTMF and CTMS systems for trial documentation and management.
• Serve as the principal project lead and liaison for internal teams and external collaborators.
• Coordinate efforts across functional units including monitoring, site management, data management, pharmacovigilance, regulatory affairs, IP supply, and medical writing.
• Ensure all involved personnel are well trained on protocol and operational needs.
• Act as the main client contact for trial operations, managing deliverables and issue resolution.
• Conduct and lead regular status meetings with stakeholders, aligning on progress, risks, and timelines.
• Proactively identify, assess, and mitigate risks and issues throughout the trial lifecycle.
• Oversee regulatory submissions to IRBs/ECs and review of informed consent documents as necessary.
• Ensure compliance with internal quality standards and external regulations; support quality assurance audits and investigations as needed.
• Manage project financials including budgets, scope, and vendor negotiations, ensuring invoice approvals and site payments align with agreements.
• Ensure all trial documentation is accurate, complete, and stored within internal systems adhering to quality standards.

Candidate Profile

• Bachelor’s degree, preferably in a health or science discipline.
• At least 5 years of experience managing clinical trials or clinical research projects.
• Proven track record in overseeing clinical trials from start to finish.
• Strong knowledge of ICH GCP guidelines and clinical trial procedures.
• Demonstrated capacity to lead cross-functional teams and juggle multiple priorities effectively.
• Excellent organizational, problem-solving, and decision-making abilities.
• Effective written and verbal communication skills.
• Proficient in Microsoft Office suite.
• Willingness and ability to travel as business needs dictate.

Additional Information

• The job level offered will depend on experience and skills demonstrated during the recruitment process.
• As seniority increases, responsibilities and project scope may broaden.
• Candidates must live in a U.S. state where the company is authorized to employ; residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia are not eligible.
• WEP Clinical provides a comprehensive benefits package including medical, dental, vision insurance, FSA/HSA, voluntary critical illness, hospital indemnity, accident insurance, disability coverage, life insurance, 401(k) with company match, paid leave, and parental leave.
• The organization values wellness, growth, inclusivity, and respects diverse perspectives, aiming to cultivate professional development and a supportive work environment.
• WEP Clinical operates as a smoke-, drug-, and alcohol-free workplace and adheres to equal employment opportunity principles, ensuring fair treatment regardless of protected characteristics.
• The company employs AI tools in recruitment for efficiency but final employment decisions are human made.
• Applicants should be aware of official communication channels; no contact will be made through Microsoft Teams or text messages, nor will personal financial information ever be requested.

About WEP Clinical Services

Services include clinical trial delivery, home health, expanded access programs, market access consultancy, and more, with global reach spanning over 150 countries, merging scale with specialized personalized service to bridge care gaps and expedite access to treatments.

Data Privacy

The company is committed to protecting applicant personal information in line with its privacy policies throughout the hiring process.