Senior Clinical (Trials) Manager

The role:

• 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 the management of Contract Research Organizations (CRO’s);
• Assist in authoring protocol and related documents, development of study tools, guidelines and training materials;
• Manage clinical study material, oversee vendors and other third parties and assist in the implementation plan(s); risk management, oversight management plans, data review processes, TMF review plans and execution, oversight monitoring plans and execution in addition to 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 and provision of information to management team 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 Executive Director & Director of Clinical Operation 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 of 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 

Your Profile :

• Advanced (e.g. Masters) degree or equivalent education / degree in life sciences / healthcare;
• 6-8 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.

Our offer :