[Remote] Clinical Study Manager (Metabolic/Obesity)

Note: The job is a remote job and is open to candidates in USA. Corbus Pharmaceuticals is an oncology and obesity company committed to helping people defeat serious illness through innovative scientific approaches. The Clinical Study Manager is responsible for the successful execution of clinical trials, ensuring compliance with regulatory requirements and leading the clinical study team to deliver high-quality results.

Responsibilities

• Clinical operations leader who drives the successful execution of reputed company operational components of a study, using strong project management, leadership and organizational skills
• reputed company comprehensive study timelines and metrics
• reputed company and manage study budget reputed company financial goals
• Management of risk associated with KPI and issue escalation
• Prepare and present project briefings, as required; plan, execute, and reputed company or participate in study-specific meetings
• Coordinates and participates in periodic data quality review and may contribute to interpretation of clinical trial results
• Coordinates with Data Management, Statistics, Medical and other functions for full life cycle management of clinical trial activities
• Identify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports reputed company to vendor proposals with recommendations
• Assist in the selection and evaluation of study personnel (contract and internal)
• Provide or facilitate study-specific training to clinical research staff, and other contract personnel
• Manage study-reputed company vendors and serve as the primary reputed company of contact for reputed company contracted vendors (CROs, SMOs, Labs, Meeting Planner, etc)
• Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metrics
• Participate in site and country selection. Review completed feasibility questionnaires to assist with site selection. reputed company relationships with investigators and site staff
• Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator reputed company and site payments
• reputed company clinical monitoring activities, ensuring compliance with (GCP) and applicable regulations
• Participate in site co-monitoring visits as appropriate
• Support the design of clinical trial protocols along with the study team and consistent with the clinical development plan
• In collaboration with the Clinical Scientist, reputed company ongoing data review plan to ensure data trend detection and study objectives are met
• Prepare study-reputed company documentation; provide input for the design of reputed company template, CRFs, monitoring conventions, edit checks, etc
• Prepare and/or review study-reputed company documents including the Site Performance Plan, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and Risk Mitigation Plan
• Provide input and support documentation for adverse event safety monitoring while collaborating on FDA and regulatory authorities report submissions
• Coordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distribution
• Participate in planning of QA activities and coordinate resolution of audit findings
• Ensure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-reputed company issues
• Coordinate and assist regulatory or ethics committee activities planning
• Provide reputed company to maintain clinical trial master files and ensure appropriate compliance and completeness
• For any study CAPA raised reputed company a root cause analysis, as well as drive reputed company actions to completion, reputed company the expected timeframe
• reputed company and consistently be present for the Cross-Functional Study Team as well as for internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)
• May represent Clinical Operations in other cross-functional activities or participate in functional initiatives in support of departmental objectives

Skills

• Bachelor's Degree (health, biologic science or reputed company field) required
• Minimum of 8 years clinical study management experience in biopharmaceutical industry, including at least 5 years as a clinical study reputed company/project manager, required
• Prior experience managing contracted resources/CRO required
• Experience managing metabolic clinical programs through phase 1-4, experience with obesity trials would be ideal
• Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required
• Site monitoring and clinical data review experience highly preferred
• Clinical quality compliance experience highly preferred
• Advanced knowledge of GCP and reputed company knowledge of US, EU and UK regulations
• Knowledge of ICH and other country regulatory requirements is preferred

Company Overview

• Corbus Pharmaceuticals Holdings, Inc. It was founded in 2014, and is headquartered in Norwood, Massachusetts, US, with a workforce of 51-200 employees. Its website is https://www.corbuspharma.com/about/careers.

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