Senior Clinical Trials Manager

Role Summary

Senior Clinical Trials Manager (US-based) responsible for the end-to-end operational management of oncology clinical trials. You will lead CRO oversight, study start-up, data review, enrollment activities, and cross-functional collaboration to ensure deliverables are met on time, within budget, and in compliance with quality standards. You will also support protocol development, regulatory submissions, and trial budgeting across global sites.

Responsibilities

• Ensure all operational trial deliverables are met according to timelines, budget, operational procedures, quality/compliance and performance standards under management of the Executive Director of Clinical Operations. This includes management of CROs.
• Assist in authoring protocol and related documents, development of study tools, guidelines and training materials.
• Manage clinical study materials; oversee vendors and third parties; assist in implementation plans; risk management; oversight management plans; data review processes; TMF review plans and execution; oversight monitoring plans and execution; start-up, execution and close-out of clinical trials.
• Global clinical trial experience in Oncology across multiple countries/regions.
• Manage regular thorough clinical data review (at Merus and through CROs) to ensure it occurs on time, and there is timely query resolution at CROs and clinical sites.
• Drive enrollment and recruitment activities and initiatives; provision of information to management through site enrollment meetings, board slide preparation, management reports and dashboards.
• Support the development, management and tracking of trial budgets with the appropriate partners internally and externally.
• Lead internal Operations team meetings and co-lead Clinical Trial Team (CTT) meetings with the CRO.
• Participate in the organization and logistics of various trial-related committees.
• Manage site-related issues and procedural questions; support the Executive Director and Director of Clinical Operations in the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, all plans etc.
• Assist with program-level activities (e.g., development of clinical sections of regulatory documents such as Investigators’ Brochures, DSUR/PSUR, IND/NDA submission documents) and provide support, as needed, for HA and/or IRB/IEC inquiries.
• Participation in CRA calls to assist with site follow-up, recruitment, training, protocol deviation finding resolutions, trip report review findings and overall CRA training.
• Review TMF and assistance with remediation of findings along with Clinical Trial Associates (CTAs).
• Manage site engagement and site relationships through communications and visits with clinical sites and cross-functional collaboration with Medical Affairs and Clinical Development.
• Review of Monitoring Trip Reports and provision of timely tracking of comments and suggested remediation actions to the CRO.
• Participation in oversight monitoring visits at clinical trial sites.

Qualifications

• 4–5 years of experience in clinical development.
• Experience with cross-functional clinical trials; capabilities in supporting operational aspects of clinical trial related activities (planning, executing and reporting) as well as the clinical/scientific aspects.
• Clinical Research Associate experience is strongly preferred and knowledge of how to conduct source data verification (SDV) and how to execute all types of monitoring visits – Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) and Close Out Visits (COVs).
• Knowledge of GCP (Good Clinical Practice), comprehensive knowledge of clinical trial design and a good understanding of the overall drug development process; basic knowledge of oncology is preferred.

Education

• Advanced degree (Masters) in life sciences/healthcare or equivalent.

Skills

• CRO/vendor management and oversight
• Clinical trial start-up, monitoring, and data review; TMF oversight
• Trial budgeting and financial tracking
• Regulatory document support (Investigators’ Brochures, DSUR/PSUR, IND/NDA)
• Cross-functional collaboration and leadership
• Site engagement and CRA liaison; communication and training
• Knowledge of GCP and oncology trial design