Are you ready to join our fight against cancer?
The team:
The Clinical Operations team is responsible for all of the clinical trials we conduct for our product candidates. Currently we have four product candidates in phase I/II studies in oncology, most of them first in class compounds.
The role:
As a Senior Clinical (Trials) Manager, your main tasks and responsibilities are the following:
* 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 (CROs);
* 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:
When hiring new employees, we look for people who will fit in well with the collaborative, rigorous, and entrepreneurial spirit of our company – a spirit that drives us to develop advanced therapies that address unmet needs in cancer treatment.
* 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:
We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours and a company bonus structure. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
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