Clinical Trial Manager

## About the Role As a Clinical Trial Manager at Generate Biomedicines, you will play a critical role in the operational execution of late-stage clinical trials. You will serve as a key day-to-day operational coordinator across assigned studies, working closely with external partners such as CROs and vendors. Your attention to detail and ability to manage multiple trackers and timelines simultaneously will be essential in ensuring the successful execution of these trials. The Clinical Trial Manager role is an excellent opportunity for a detail-driven professional looking to grow their clinical operations career on the sponsor side. You will have the chance to work with a network of CROs and specialized vendors, monitoring deliverables, flagging issues, and coordinating internally. Your expertise will be invaluable in ensuring that these external partners stay on track and that clinical operations leadership is informed of any risks or delays. You will report to the Director, Clinical Operations, and will be part of a dynamic team that is passionate about delivering high-quality clinical trials. Your experience working with CROs and vendors will be highly valued, as well as your ability to communicate effectively and escalate issues in a timely manner. ## What You Will Do - Serve as a day-to-day operational point of contact for assigned CROs and vendors, tracking study deliverables and timelines and flagging risks or delays to clinical operations leadership - Review CRO-generated study documents for completeness and quality, including monitoring visit reports, site correspondence, protocol deviations, and TMF entries - Support the coordination of study startup activities, including site activation tracking, regulatory document collection, and vendor kick-off preparation - Maintain and update study trackers, timelines, and action logs; ensure cross-functional teams have visibility into study status and open items - Attend and support cross-functional study team meetings; document meeting minutes, track action items, and follow up on outstanding deliverables - Track and triage protocol deviations reported by CROs; coordinate with vendors and internal teams to ensure timely documentation and resolution - Support safety reporting coordination, including tracking SAE/SUSAR notifications and ensuring timely distribution to sites and relevant stakeholders in line with vendor responsibilities - Monitor TMF completeness and support inspection readiness activities, working with CROs to resolve filing gaps and maintain document quality standards - Assist with IRB/IEC tracking across study sites, including monitoring approval status for amendments and annual renewals submitted by the CRO - Compile and distribute enrollment, site performance, and operational metrics to clinical operations leadership on a regular basis - Contribute to data reviews as needed, and track data cleaning progress performed by CRO - Review and track monitoring visits and monitoring visit reports performed by CRO to ensure high quality and adherence to the monitoring plan - Support vendor invoice review and budget tracking by reconciling CRO invoices against contracted activities and flagging discrepancies - Coordinate data reconciliation activities at key study milestones in collaboration with data management and the CRO - Support the onboarding of CTAs joining the study team and serve as a resource for day-to-day study questions

## What We Are Looking For - Bachelor’s degree required; scientific or health-related field preferred - 6+ years of experience in clinical operations, clinical research, or a related field; sponsor-side experience is a plus - Foundational understanding of GCP, ICH guidelines, and clinical trial processes - Experience working with or alongside CROs or clinical vendors in a coordination or support capacity - Strong attention to detail and ability to manage multiple trackers, timelines, and action items simultaneously - Comfortable working in a structured, vendor-managed model where the role is one of oversight and coordination rather than direct execution - Familiarity with clinical trial systems such as CTMS, EDC, and eTMF platforms - Clear communicator with the ability to follow up consistently and escalate issues in a timely manner - Familiarity with therapeutic areas such as oncology, immunology, and/or respiratory is a plus - Ability to travel up to 20% of the time, domestically and/or internationally

## Nice to Have - Experience with Excel and other Microsoft Office tools - Knowledge of regulatory requirements and guidelines - Familiarity with project management tools and software - Certification in clinical research or a related field

## Benefits and Perks - Competitive salary and benefits package - Opportunity to work with a dynamic and growing company - Collaborative and supportive work environment - Professional development and growth opportunities - Flexible working hours and remote work options - Access to cutting-edge technology and tools - Recognition and reward for outstanding performance - Comprehensive health and wellness programs - Paid time off and holidays

- To stand out as a candidate, be sure to highlight your experience working with CROs and vendors, as well as your attention to detail and ability to manage multiple trackers and timelines.

• Familiarize yourself with the company’s therapeutic areas of focus, such as oncology and immunology, to demonstrate your knowledge and interest in the field.
• Be prepared to provide specific examples of your experience with clinical trial systems, such as CTMS and eTMF platforms, and your ability to communicate effectively with cross-functional teams.
• Consider obtaining certification in clinical research or a related field to demonstrate your expertise and commitment to the profession.
• When negotiating salary, be sure to research the market rate for Clinical Trial Managers in your area and be prepared to discuss your qualifications and experience.
• Be aware of the company’s remote work policy and be prepared to discuss your ability to work independently and manage your time effectively.