Clinical Study Manager

Role Summary

The Clinical Study Manager is responsible for the successful execution of clinical trials from protocol conception through to clinical study report. The Clinical Study Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues. This role is accountable for leading the extended clinical study team and supporting the strategic planning and execution of clinical trials ensuring compliance with regulatory and legal requirements, ensuring high quality execution, clinical trial participant safety and data integrity.

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
• This role reports directly to the Senior Director, Clinical Operations.

Qualifications

• Bachelor‚Äôs 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
• Site monitoring and clinical data review experience highly preferred
• Clinical quality compliance experience highly preferred
• Advanced knowledge of GCP and current knowledge of US, EU and UK regulations
• Knowledge of ICH and other country regulatory requirements is preferred
• Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required