Clinical Research Coordinator, Sr.

2 months ago

Cambridge, Cambridgeshire, United Kingdom Merus Netherlands Full time
About the Role:

We are seeking a highly experienced and skilled Senior Clinical Trials Manager to join our Clinical Operations team at Merus Netherlands. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials, from start to finish.

Key Responsibilities:
  • Operational Trial Deliverables: 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.
  • Protocol and Document Authoring: Assist in authoring protocol and related documents, development of study tools, guidelines and training materials.
  • Clinical Study Management: 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: Global clinical trial experience in Oncology across multiple countries/regions.
  • Clinical Data Review: 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.
  • Team Leadership: Lead internal Operations team meetings and co-lead Clinical Trial Team (CTT) meetings with the CRO.
  • Site Management: 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.
  • Regulatory Document Development: 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.
  • CRA Support: Participation in CRA calls to assist with site follow-up, recruitment, training, protocol deviation finding resolutions, trip report review findings and overall CRA training.
  • TMF Review: Review of TMF and assistance with remediation of findings along with Clinical Trial Associates (CTAs).
  • Site Engagement: Manage site engagement and site relationships through communications and visits with clinical sites and cross-functional collaboration with Medical Affairs and Clinical Development.
  • Oversight Monitoring: Participation in oversight monitoring visits at clinical trial sites.
Requirements:
  • Education: Masters) degree or equivalent education/degree in life sciences/healthcare;
  • Experience: 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: 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);
  • GCP Knowledge: Knowledge of GCP (Good Clinical Practice), comprehensive knowledge of clinical trial design and a good understanding of the overall drug development process;
  • Oncology Knowledge: Basic knowledge of oncology is preferred.
About Merus:

We are a biotech company dedicated to developing innovative therapies for cancer treatment. Our team is passionate about making a difference in the lives of patients and their families. We offer a competitive salary, flexible working hours and a company bonus structure. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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