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Xeris Pharmaceuticals, Inc. · 6 days ago

Clinical Project Manager

US-IL-Chicago

Full-time

Hybrid

Senior Level

$100K/yr - $170K/yr

6+ years exp

Xeris Pharmaceuticals, Inc. is focused on innovative therapies, and they are seeking a Clinical Project Manager to oversee the operational aspects of clinical trials. The role involves managing clinical studies, ensuring compliance with regulatory requirements, and collaborating with internal and external stakeholders for successful trial outcomes.

BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics

Responsibilities

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

Qualification

Clinical trial managementCRO oversightICH/GCP knowledgeEClinical toolsBudget managementProject ManagementTeamwork & CollaborationVerbal CommunicationWritten CommunicationAdaptability

Required

Bachelor's degree (BA/BS) or equivalent in life sciences or equivalent

6+ years executing clinical programs required

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

Preferred

Global clinical trial experience a plus

Experience in endocrinology preferred

Benefits

Bonus

Equity

Multiple paid time off benefits

Various health insurance options

Retirement benefits

Company

Xeris Pharmaceuticals, Inc.

We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.

Founded in 2005

Chicago, Illinois, USA

201-500 employees