Clinical Project Manager

Quiddity Talent Solutions; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Quiddity Talent Solutions is seeking an experienced Clinical Project Manager to lead international oncology and general medicine trials, ensuring on-time, on-budget delivery and strict adherence to ICH-GCP and SOPs.

You will manage cross-functional teams, sponsor relationships, and study budgets from start-up through close-out, driving operational excellence and overseeing vendors as needed.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Significant CRO/pharma project management experience in Oncology/General Medicine.
• Experience with end-to-end clinical trial lifecycle and global studies.
• Familiarity with ICH-GCP and sponsor requirements.
• Experience with CTMS/eTMF and trial-management systems.

Responsibilities

• Lead end-to-end delivery of global clinical studies from feasibility to close-out.
• Develop project plans, timelines, risk registers, and tracking tools.
• Coordinate cross-functional teams across Clinical Operations, Regulatory, Biometrics, Medical, Pharmacovigilance, and Vendor Management.
• Proactively identify project risks and implement mitigation strategies.

Skills

Project management

Stakeholder management

Budget management

Cross-functional leadership

Education

Bachelor's degree in Life Sciences

Tools

CTMS

eTMF

Microsoft Office

Job description

Are you an experienced Clinical Project Manager with Oncology and/Or General Medicine experience looking for a role where you can take genuine ownership of international clinical studies while remaining closely involved in the operational delivery of clinical trials?

We are partnering with a leading global Contract Research Organisation (CRO) to appoint an experienced Clinical Project Manager to oversee the successful delivery of international clinical trials from study start-up through to close-out. Working as the primary point of contact for sponsors, you will lead project planning, execution, financial oversight, and cross-functional collaboration to ensure studies are delivered on time, within budget, and in compliance with ICH-GCP, applicable regulations, and internal quality standards.

This opportunity is suited to a proactive project leader with excellent stakeholder management skills, commercial awareness, and the ability to manage multiple priorities while driving operational excellence.

Key Responsibilities

• Lead the end-to-end delivery of global clinical studies, from feasibility and site selection through to database lock and study close-out.
• Develop and maintain project plans, timelines, risk registers, and study tracking tools.
• Coordinate cross-functional teams across Clinical Operations, Regulatory Affairs, Biometrics, Medical, Pharmacovigilance, and Vendor Management.
• Proactively identify project risks and implement mitigation strategies to support successful study delivery.
• Ensure projects are conducted in accordance with study protocols, ICH-GCP, applicable regulations, and company SOPs.

Client & Stakeholder Management

• Act as the primary point of contact for sponsors throughout the project lifecycle.
• Build strong client relationships through regular communication, project updates, and proactive issue resolution.
• Lead project meetings, governance calls, and support business development activities, including bid defence meetings where required.
• Partner with commercial teams during feasibility assessments and change order discussions.
• Manage project budgets, revenue forecasts, profitability, and overall financial performance.
• Monitor project scope and coordinate change orders where appropriate.
• Ensure effective project resourcing and workload planning.
• Oversee external vendors and service providers to ensure high-quality delivery.

Site & Study Management

• Oversee site selection, activation, patient recruitment, monitoring, and study close-out activities.
• Support ethics and regulatory submissions in collaboration with Clinical Operations and Regulatory teams.
• Monitor recruitment performance and implement strategies to optimise enrolment and site productivity.
• Maintain inspection and audit readiness throughout the study lifecycle.
• Provide leadership, mentoring, and support to cross-functional project teams, including Associate Project Managers where applicable.
• Foster a collaborative, accountable, and high-performing project environment.
• Contribute to process improvements, SOP development, and operational excellence initiatives.
• Represent the organisation professionally with sponsors, investigators, and external stakeholders.

About You

You are an experienced clinical project leader with excellent organisational, leadership, and communication skills. You enjoy working in a collaborative, fast-paced environment and are passionate about delivering high-quality clinical research while building trusted relationships with sponsors and study teams.

Qualifications & Experience

• Bachelor's degree in Life Sciences, or a related discipline.
• Significant clinical project management experience ideally within Oncology and/or General Medicine and within a CRO, pharmaceutical, or biotechnology environment.
• Strong understanding of the end-to-end clinical trial lifecycle, including study start-up, site management, patient recruitment, data management, and study close-out.
• Comprehensive knowledge of ICH-GCP, global clinical trial regulations, and sponsor requirements.
• Proven experience managing global, cross-functional project teams, budgets, timelines, and project risks.
• Demonstrated client-facing experience with the ability to develop long-term sponsor relationships.
• Experience using CTMS, eTMF, Microsoft Office, and other clinical trial management systems.
• Excellent communication, negotiation, and stakeholder management skills.