Note: The job is a remote job and is open to candidates in USA. Corbus Pharmaceuticals is a clinical-stage biotechnology company developing therapies in oncology and obesity. The Clinical Trial Manager is responsible for the day-to-day operational management and execution of assigned clinical trials from study planning through closeout, coordinating cross-functional teams and overseeing CROs and vendors. The role manages study timelines, budgets, risks, quality, regulatory compliance, site activities, and clinical trial documentation.
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 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
Skills
- 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
- Site monitoring and clinical data review experience
- Clinical quality compliance experience
- Advanced knowledge of GCP and current knowledge of US, EU and UK regulations
- Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required
- Experience with oncology
- Knowledge of ICH and other country regulatory requirements
Benefits
- Hybrid work arrangement in Norwood, Massachusetts: onsite 3 days a week
- Remote work option with monthly travel to Norwood, Massachusetts
- Work arrangement based in the Greater London area with some travel to the United States
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