What are the responsibilities and job description for the Senior Clinical Trials Manager position at Merus?
Senior Clinical Trials Manager
Application Deadline : 19 March 2025
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.
Our offer :
We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you'll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you'll have the chance to help us close in on cancer - everything you do matters at Merus.
