Clinical Trial Manager

The Clinical Trial Manager (CTM) is responsible for the day-to-day operational management and execution of assigned clinical trials from study planning through closeout. Working with appropriate oversight from Clinical Operations leadership, the CTM leads study execution, coordinates the cross-functional study team, and provides sponsor oversight of CROs and other external vendors to ensure study milestones, quality, budget, and operational objectives are achieved.

The CTM is expected to independently manage study activities, identify and address operational risks and issues, drive routine study decisions, and appropriately elevate significant risks, issues, or decisions. The CTM applies sound judgment and initiative while ensuring trials are conducted in accordance with the protocol, applicable regulatory requirements, ICH-GCP, company procedures, and quality standards.

This role can be hybrid to Norwood, Ma onsite 3 days a week or remote with monthly travel to Norwood, Ma or based in greater London area with some travel to US.

RESPONSIBILITIES

• Ensure compliance with protocol and overall objectives across all investigator sites
• Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
• Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
• Execute study activities according to study protocol, regulatory guidelines and operational plans
• Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
• Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
• Participate in study start-up, conduct and closeout activities
• Assist in preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
• Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
• Assemble and distribute regulatory binders to clinical sites
• Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
• Lead study team meetings and ensure appropriate agendas, meeting documentation, action items, decision logs, study trackers, and follow-up are maintained; perform these activities directly as needed. Assist with preparation and distribution of investigator site contracts and budgets
• Maintain the Trial Master File all clinical projects
• Lead the day-to-day operational execution of assigned clinical trials, with appropriate oversight from Clinical Operations leadership, using strong project management, leadership, judgment, 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 completion
• 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

Requirements

• 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 clinical programs through phase 1-4, experience with oncology is preferred
• 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

Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies in oncology and obesity. Our mission is to help people defeat serious illness by advancing differentiated scientific approaches targeting well-understood biological pathways with significant unmet medical need. Corbus’ lead oncology program, CRB-701, is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4-expressing tumors and is being developed for multiple solid tumor indications. Our obesity program, CRB-913, is a highly peripherally restricted CB1 receptor inverse agonist designed to support meaningful weight loss while minimizing central nervous system side effects. Together, these programs reflect our commitment to advancing transformative therapies through rigorous science and clinical innovation.

Headquartered in Norwood, Massachusetts, Corbus fosters a collaborative, entrepreneurial environment where employees are empowered to make meaningful contributions and help shape the future of the company. For more information, visit corbuspharma.com and connect with us on LinkedIn.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.