layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Manager, Clinical Project Management (Project Delivery) at Immunome | LAYIQ

Clinical
Project Delivery
Lead cross functional facilitation of clinical study teams through the trial lifecycle.
Own study-level timeline development, tracking, and reporting for assigned trials.
Develop and maintain enrollment graphs and dashboards, ensuring accuracy and timel y updates to inform decision-making.
Monitor project delivery metrics ( timelines, milestones
, enrollment, budget adherence, vendor KPIs) and ensure correcti ve action when studies are at risk.
Facilitate or support cross-functional planning, execution, and delivery of assigned clinical trials on time, w ith in budget, and to quality standards.
Help the clinical study team (CST) i dentify operational risks and implement mitigation strategies to ensure successful trial delivery.
Clinical Operations
Champion a culture of accountability, collaboration, and continuous improvement.
May contribute to functional and/or departmental initiatives.
May mentor new or junior team members.
Vendor Management
Manage
CRO and Central lab relationships and oversight for assigned studies.
Initiate vendor identification, selection, contracting, and onboarding activities in support of Finance, Legal, and clinical study teams.
M anage and m onitor vendor performance against contractual obligations, operational timelines, and quality and performance metrics.
S upport vendor governance meetings, oversight activities, issue escalation, and resolution to ensure timely and effective trial execution.
Quality Assurance and Regulatory Compliance
Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements for assigned trials.
Work with Quality Assurance and the CST to support and ensure ongoing inspection r eadiness and implement corrective actions as needed.
Help ensure data integrity and consistent trial conduct across assigned trials.
Cross-Functional Collaboration
Align cross-functionally on program objectives and study execution plans
, including
Clinical Site & Trial Operations, Clinical Field Monitoring & Trial Operations, and Clinical Developm ent Systems.
Work with cross-functional teams to identify and mitigate study delivery risks.
Provide study-level operational input into program-level discussions an d decisions.
Support regulatory submissions (INDs, NDAs, BLAs) and health authority interactions as needed for assigned studies.
Budget and Resource Management
Work with Finance to support manage ment and forecast ing of study-level budgets, including change orders, ensuring alignment with corporate priorities and program timelines.
Maintain financial oversight for vendor and study-related activities with strict oversight of Change Orders and Change Notifications.
Track and report on budget adherence for assigned studies.

Senior Manager, Clinical Project Management (Project Delivery)

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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