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Corbus Pharmaceuticals · 1 day ago

Clinical Study Manager (Metabolic/Obesity)

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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.

Pharmaceuticals

Hiring Manager

Tim Fay

Responsibilities

Clinical operations leader who drives the successful execution of all operational components of a study, using strong project management, leadership and organizational skills

Develop comprehensive study timelines and metrics

Develop and manage study budget within financial goals

Management of risk associated with KPI and issue escalation

Prepare and present project briefings, as required; plan, execute, and lead 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 related 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-related vendors and serve as the primary point of contact for all 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. Develop relationships with investigators and site staff

Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site payments

Oversee 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, develop ongoing data review plan to ensure data trend detection and study objectives are met

Prepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc

Prepare and/or review study-related 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-related issues

Coordinate and assist regulatory or ethics committee activities planning

Provide oversight to maintain clinical trial master files and ensure appropriate compliance and completeness

For any study CAPA raised perform a root cause analysis, as well as drive all actions to completion, within the expected timeframe

Lead 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

Qualification

Clinical study managementGCP knowledgeProject managementBiopharmaceutical experienceMetabolic clinical programsRegulatory complianceTeam-building skillsLeadership skillsCommunication skillsProblem-solving skillsConflict resolution

Required

Bachelor's Degree (health, biologic science or related field) required

Minimum of 8 years clinical study management experience in biopharmaceutical industry, including at least 5 years as a clinical study lead/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