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Full-time

Clinical Trial Project Manager

Competitive

Specialist CRO for clinical trials, expanded access programsScience & PharmaceuticalPosted 30+ Days Ago

You'll complete your application on the employer's website.

Job description

WEP Clinical partners with biopharmaceutical sponsors to support clinical trial delivery, patient access, and drug development. The Clinical Trial Project Manager leads the setup, execution, and close-out of clinical trials while ensuring patient safety, data integrity, regulatory compliance, and delivery within scope, timeline, and budget. The role also manages cross-functional teams, client relationships, risks, vendors, and trial documentation.

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

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

Preferred

  • Bachelor's Degree (health or science field preferred)

Bachelor’s Degree

Science Field

Benefits

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

WEP has many initiatives to encourage wellness, growth and development, and team relationships

Inclusive, supportive environment

Company

Specialist CRO for clinical trials, expanded access programs.

London, England, GBR

http://www.wepclinical.com/

Founded in 2008

501-1000 employees

Qualifications

  • Adaptable
  • Detail-oriented
  • Collaborative
  • Solutions-focused
  • 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
  • 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
  • Bachelor's Degree (health or science field preferred)
  • Minimum 5 years’ experience in a Project Manager role within clinical trials or clinical research

Required skills

Clinical Trial Project Management, Clinical Trial Management, ICH GCP Guidelines, Clinical Trial Processes, Microsoft Office

Preferred skills

  • Bachelor's Degree (health or science field preferred)

Experience

5+ years

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