Clinical Project Manager

Role & responsibilities

• Manages an assigned portfolio of clinical studies under regular guidance from the Associate Director or designee, developing toward increasingly independent study execution as experience and competency grow.
• Develops, maintains, and manages all study-specific documentation and deliverables applicable to assigned studies, including study execution plans, data review plans, imaging charters, timelines, and status reports; may consult with the Associate Director or designee for guidance as needed.
• Serves as the primary internal and external point of contact for assigned studies; leads cross-functional study teams in executing against protocol requirements, project timelines, and quality standards; escalates issues and risks to the Associate Director or designee in a timely manner.
• Proactively identifies potential study risks and contributes to the development and implementation of mitigation actions; communicates findings to the Associate Director or designee and relevant internal stakeholders.
• Supports user acceptance testing (UAT) and build specification reviews for applicable systems and platforms used in assigned studies; documents findings and escalates issues to the Associate Director or designee and relevant internal teams as needed.
• Manages an assigned portfolio of clinical studies under regular guidance from the Associate Director or designee, developing toward increasingly independent study execution as experience and competency grow.
• Develops, maintains, and manages all study-specific documentation and deliverables applicable to assigned studies, including study execution plans, data review plans, imaging charters, timelines, and status reports; may consult with the Associate Director or designee for guidance as needed.
• Serves as the primary internal and external point of contact for assigned studies; leads cross-functional study teams in executing against protocol requirements, project timelines, and quality standards; escalates issues and risks to the Associate Director or designee in a timely manner.
• Proactively identifies potential study risks and contributes to the development and implementation of mitigation actions; communicates findings to the Associate Director or designee and relevant internal stakeholders.
• Supports user acceptance testing (UAT) and build specification reviews for applicable systems and platforms used in assigned studies; documents findings and escalates issues to the Associate Director or designee and relevant internal teams as needed.
• Escalates complex operational, sponsor-facing, or cross-functional issues to the Associate Director and/or department head in a timely manner.
• Maintains working knowledge of assigned client contracts, deliverables, key performance indicators, and key client agreements including Service Level Agreements, Governance Agreements, and Rate Cards.
• Consistently performs all duties in accordance with established Policies, SOPs, Work Instructions, Study-Specific Procedures, and applicable regulations including GCP, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, and HIPAA; raises observed gaps or inconsistencies to the Associate Director or designee for review.
• Participates in financial tasks including monthly billing, forecasting, scope reviews, and amendments under the guidance of the Associate Director.
• Participates in internal and external project-related audits in a supporting capacity; provides study documentation and responds to auditor queries as directed by the Associate Director or Sr. CPM.
• Assists with all other departmental requests as needed.