Company:  Confidential

Job Title: Senior Clinical Study Manager

Job Number: 73607

Location: Remote, US

Job Description

A well diversified, growing biopharmaceutical company focused on therapies within hematology, immunology, and neurology. Manage the end to end delivery of global clinical trials, covering scientific and operational activities, including phase I to IV clinical trials Ensure that clinical trials are conducted in compliance with applicable regulations and company policies and procedures as well as adhere to timelines and budget, while ensuring patient safety and data quality. Support and contribute to ongoing process improvement workstreams.

Responsibilities

Responsible for ensuring that all activities are completed for assigned clinical trials to agreed timelines, budgets and data quality standards.  Activities include but are not limited to the following:  * Feasibility/Recruitment – Identification and selection of investigators willing to participate in clinical trials and managing study recruitment with respect to timelines and budget. Prepare and review study recruitment and retention materials, in conjunction with any partner CRO project manager. * Ensures prompt, quality communications with CROs/sites regarding protocol clarification and procedural queries annual (safety) reports, clinical study reports and other trial documentation, to standards required by company Ongoing data review and assisting with site issue resolution * Ensure Trial Master File is correctly set up, regularly maintained and archived * Providing regular progress updates to clinical research team and cross-functional project team  * Delivery of Clinical Trial– Includes set-up, maintenance and close-out procedures.  Ensuring prompt identification and resolution upon any patient or trial related problems to satisfactory conclusion.  Overall management of clinical trial with respect to patient safety, objectives, timelines and budget.  This includes: * Development, review and finalization of study-specific plans and forms, including case report forms and statistical analysis plans * Ensure correct reporting of safety events * Monitoring/co-monitoring at study sites to standards required by company Additional responsibilities will include: Investigational Medicinal Product (IMP) and Supplies Management CRO and Vendor Management Budget Management Risk Management Strategies Quality Assurance and Audits Meeting Management

Required Skills

* A working knowledge of Good Clinical Practice and relevant regulatory requirements  * Science degree or equivalent * Relevant work experience within the clinical research environment within the Pharmaceutical or allied Industry * 6+ years of study management experienceExpected salary range 160-180k with annual bonus and extensive benefits package

Application Deadline: 2024-03-18

 

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