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Upstream Bio · 4 days ago

Senior Manager, Clinical Trial Management

Waltham, MA

Full-time

Onsite

Senior Level

$162K/yr - $198K/yr

6+ years exp

Upstream Bio is a public company based in Waltham, MA, developing innovative therapies for severe asthma and chronic rhinosinusitis. They are seeking a Senior Manager for Clinical Trial Management to oversee the planning and execution of clinical trials, ensuring compliance with regulations and quality standards while managing cross-functional teams and vendor relationships.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Lead or contribute to cross functional trial execution from planning to close-out, in alignment with the Indication Lead, program strategy and company goals

Provide operational management of clinical trials including trial budget, tracking & reporting of trial deliverables, developing and managing timelines

Contribute to and oversee internal and external project materials, including study plans, manuals & specifications, systems, and regulatory submissions

Support site trial conduct and help foster relationships with site staff and KOLs

Ensure audit and inspection readiness and compliance across all clinical trial activities, including completeness of the TMF

Lead and contribute to the successful conduct of the Study Team Meeting and other operational forums

Contribute to CRO/vendors identification, selection and oversight; Provide oversight for relevant vendors-related activities, including contracting, budgeting and documentation

Closely collaborate with CRO/vendors & key stakeholders to secure end-to-end data integration activities (i.e. eCOA, EDC, labs, imaging), including review of data specifications

Assess, manage, mitigate and report risks throughout the trial. Collect and analyze qualitative and quantitative oversight data to identify risks and manage mitigations, investigations, action plans, and resolution

Contribute to other activities, such as team training, process development etc