Clinical Project Manager

Role Summary

The Clinical Project Manager (CPM) will be responsible for the planning, management and oversight of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight. The CPM ensures that studies are delivered on time, within budget, and in accordance with regulatory requirements, ICH/GCP, and company quality standards. The CPM acts as the central point of contact between cross functional internal teams and external vendors ensuring strategic alignment with program goals and successful trial outcomes.

The CPM may also be known as the Clinical Study Manager.

• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with study protocols, study specific plans, applicable federal and local regulatory requirements, ICH/GCP guidelines and Xeris SOPs.
• Oversee performance of CROs and clinical service providers to ensure compliance with study protocols and in accordance with scope of work, including setting expectations, training, oversight, managing timelines and deliverables, and issue management.
• Provide input to key study activities, including but not limited to site identification and selection, enrollment projections, clinical supply forecasting, organization of investigator and clinical service provider meetings, data reviews, and Clinical Study Reports.
• Track, collect, and review clinical documentation, such as risk logs, KPIs, monitoring metrics, recruitment performance, issues/actions, etc.
• Collaborate with internal and external stakeholders for the planning and execution of assigned clinical trials. Assist with development and management of project timelines and budgets.
• Review and track vendor invoices and ensure alignment with contracted scope of work.
• Write and/or contribute to the preparation of clinical protocols, amendments, informed consent forms, study plans, case report forms, and other essential study documents.
• Collaborate with legal and finance on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, etc.).
• Oversee clinical study site activities, review and approve monitoring visit reports and site communications, and visit sites as needed.
• Support TMF quality, reconciliation and inspection readiness throughout study lifecycle.
• Contribute to the development and revision of SOPs, processes, forms, templates, tools, etc. with the aim of continual improvement and efficiency.
• Support audits/inspections/inspection readiness activities, including preparation, response, and CAPA development.
• Perform other tasks or responsibilities as assigned.

• Bachelor’s degree (BA/BS) or equivalent in life sciences or equivalent.
• 6+ years executing clinical programs required. Global clinical trial experience a plus.
• Experience in endocrinology preferred.
• Experience overseeing CROs and external vendors required.
• Detailed knowledge of ICH/GCP Guidelines and current US FDA regulations.
• Experience with eClinical tools (e.g. eTMF, CTMS, EDC, etc).
• Understanding of clinical study budgets and financial management practices.
• Self-motivated and able to work independently and effectively in a matrix/team environment.
• Ability to handle multiple projects, prioritize work and meet deliverables.
• Ability to proactively problem solve with a solutions-oriented mindset.
• Highly detail-oriented with strong quality and compliance focus.
• Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.)
• Competencies:
  
  Organizational skills, Project Management, Time Management, Functional Leadership, Teamwork & Collaboration, Independent Judgement, Adaptability, Verbal and Written Communication skills

• As listed in Qualifications

• Hybrid role based in Chicago office with a minimum of three days per week in the office; on-site requirements may change.
• Periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 30%.