Senior Clinical (Trials) Manager
Senior Clinical (Trials) Manager
This role is US based.
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;
- 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.
Our offer :
Apply now
Our Hiring Process
Current Opportunities
Project Management Associate (Parttime, 20 hrs)
Translational Science
Utrecht
Merus is looking for a dedicated Project Management Associate to support our Translational Science team. This part-time position (20 hrs per week) involves a variety of o…
Supply Chain Planner
Supply Chain Management
Utrecht
Merus is seeking a skilled Supply Chain Planner to join our Supply Chain team. This role is vital for managing and overseeing the supply chain planning and execution pro…
Recruiter Life Sciences
HR
Utrecht
Join the dynamic HR team at Merus, where you will play a crucial role in sourcing and recruiting top talent to support the development of our revolutionary multispecific antib…