Clinical Project Manager

VIVEX Biologics

Clinical Project Manager leading clinical studies for VIVEX Biologics, ensuring compliance with regulations and overseeing project execution. Collaborating with R&D, Regulatory, and Marketing for successful clinical trials.

Posted 6/12/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Contributes to the development of clinical strategies aligned with regulatory and commercial goals.
Collaborates with R&D, Regulatory, and Marketing on clinical trial designs and endpoints.
Prepares and presents findings of assigned studies to internal and external stakeholders.
Leads and manages the execution of assigned clinical studies.
Oversees protocol development, site selection, budgeting, contracting, and CRO/vendor management for assigned studies.
Ensures adherence to timelines, budgets, and enrollment targets.
Manages resources and quality of clinical projects.
Ensures all clinical activities for assigned studies are compliant with FDA, ISO, and ICH-GCP regulations.
Prepares and reviews study documents including protocols, informed consent forms, monitoring plans, and clinical study reports.
Acts as a liaison with Director, Clinical Research to manage the Clinical Research Associates’ monitoring activities, reports and timelines.
Identifies study risks and proactively implements mitigation strategies.
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.

Requirements

What you’ll need

Bachelor’s degree in life sciences, nursing, biomedical engineering, or related field
5–8 years of experience in clinical research, with at least 3 years in a management or lead role
Strong knowledge of FDA regulations, ISO 14155, and ICH-GCP
Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
Experience working with CROs and clinical trial vendors
Full working proficiency in English.

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial designprotocol developmentbudgetingcontractingCRO/vendor managementclinical study reportsrisk identificationdata reviewdata capture

Soft Skills

collaborationpresentationleadershipresource managementquality managementcommunication