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Clinical Research Coordinator Senior

1 month ago

Cambridge, Cambridgeshire, United Kingdom Merus Netherlands Full time
The Clinical Operations Team

The Clinical Operations team at Merus Netherlands is responsible for the successful execution of our clinical trials. We are seeking a highly skilled and experienced Senior Clinical Trials Manager to join our team.

Key Responsibilities
  • Ensure timely and within-budget delivery of operational trial deliverables, including management of Contract Research Organizations (CROs);
  • Contribute to the development of protocol and related documents, study tools, guidelines, and training materials;
  • Oversee clinical study material, manage vendors and third parties, and assist in the implementation of clinical trials, including risk management, oversight, and data review processes;
  • Lead global clinical trial experience in Oncology across multiple countries/regions;
  • Manage regular clinical data review to ensure timely query resolution at CROs and clinical sites;
  • Lead internal Operations team meetings and co-lead Clinical Trial Team (CTT) meetings with the CRO;
  • Manage site-related issues and procedural questions, support the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, and other plans;
  • Participate 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 assist with remediation of findings along with Clinical Trial Associates (CTAs);
  • Manage site engagement and relationships through communications and visits with clinical sites and cross-functional collaboration with Medical Affairs and Clinical Development;
  • Participate in oversight monitoring visits at clinical trial sites.
Your Profile

We are looking for a collaborative, rigorous, and entrepreneurial individual who will fit in well with our company culture. The ideal candidate will have experience with cross-functional clinical trials, capabilities in supporting operational aspects of clinical trial related activities, and knowledge of clinical/scientific aspects.

  • Experience with clinical trials, including planning, executing, and reporting;
  • Clinical Research Associate experience is strongly preferred, with knowledge of source data verification (SDV) and monitoring visits;
  • Knowledge of GCP (Good Clinical Practice), clinical trial design, and the overall drug development process;
  • Basic knowledge of oncology is preferred.

We offer a competitive salary, flexible working hours, and a company bonus structure. Most importantly, you'll have the chance to contribute to the development of advanced therapies that address unmet needs in cancer treatment.