Senior Clinical (Trials) Manager

Department: Clinical Operations

Employment Type: Full Time

Location: Cambridge, MA

Description

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.

This role is US based.

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 (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

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 or 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.