What are the responsibilities and job description for the Senior Manager, Clinical Biomarker Operations position at Ventus Therapeutics?
About us :
Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.
Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.
Position overview :
The Senior Manager, Clinical Biomarker Operations plans, implements, manages, and drives biological sample logistics within Ventus clinical trials, working within our Clinical Operations function, under the leadership of the Head of Clinical Operations (or designee) and in collaboration with the Clinical Operations and cross-functional development team.
Responsibilities :
- Advise on and deliver the biosample strategy within clinical program(s) in accordance with the requirements of quality, and ethical and regulatory standards, including ICH / GCP / GLP.
- Ensure standardization and harmonization of biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation, maximizing biosample accrual and quality.
- Review clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details.
- Responsible for ensuring ethical use of biosamples collected in Ventus clinical trials.
- Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples (oversight of sample collection at site, shipment to vendor for testing / processing, analysis, final sample disposition, transfer to long term storage and oversight of sample inventory, quality and service provider)
- Ensures project level consistency occurs for biosampling across studies and is the primary point of contact for project, clinical, and study teams, contributing to innovation and improvement activities in collection, processing and data delivery.
- Track and report on biosample management status / progress, address issues, and resolutions.
- Collaborate with internal and external team members
- Lead, plan, and chair service provider meetings as needed
Requirements :