Clinical Trial Manager

About the Role

Generate Biomedicines is looking for a diligent and proactive Clinical Trial Manager (CTM) to lead the operational management of late-stage clinical trials within the Clinical Development team. Reporting to the Director of Clinical Operations, this role involves day-to-day coordination across studies and external partners.

Key Responsibilities

• Act as the primary operational liaison for CROs and vendors, monitoring project milestones and timelines while identifying potential risks or delays for escalation.
• Evaluate study documents created by CROs, ensuring completeness and quality, including reports, correspondence, protocol deviations, and Trial Master File (TMF) entries.
• Coordinate study initiation activities such as site activation tracking, regulatory submissions, and vendor onboarding preparation.
• Maintain and update trackers, timelines, and action logs to provide clear visibility of study progress to cross-functional teams.
• Participate in study team meetings, recording minutes, tracking action points, and ensuring completion of tasks.
• Manage protocol deviation tracking and resolution in collaboration with vendors and internal teams.
• Support the coordination of safety reporting by tracking serious adverse event notifications and overseeing prompt communication to sites and stakeholders.
• Monitor and ensure TMF completeness to maintain inspection readiness working closely with CROs.
• Track IRB/IEC submissions and approvals for study amendments and renewals submitted by CROs.
• Generate reports on enrollment, site performance, and operational metrics for clinical operations leadership.
• Assist with data review and track data cleaning progress with CRO involvement.
• Review and monitor CRO-conducted site visits and reports to ensure high standards and adherence to monitoring plans.
• Support vendor invoice verification and budget management by reconciling invoices with contracted deliverables and highlighting discrepancies.
• Coordinate data reconciliation activities at major study milestones with data management and CRO teams.
• Facilitate onboarding of Clinical Trial Assistants (CTAs) and serve as a resource for day-to-day study inquiries.

Candidate Profile

• Bachelor’s degree required, preferably in scientific or health-related disciplines.
• At least 6 years of experience in clinical operations, clinical research, or related fields; sponsor-side experience is advantageous.
• Solid knowledge of Good Clinical Practice (GCP), ICH guidelines, and clinical trial processes.
• Experience coordinating with CROs or clinical vendors in a support or oversight capacity.
• Exceptional attention to detail with the ability to juggle multiple trackers, timelines, and actions simultaneously.
• Comfortable in a vendor-managed framework where the role emphasizes oversight rather than direct task execution.
• Familiarity with clinical trial management systems such as CTMS, electronic data capture (EDC), and electronic TMF platforms.
• Effective communicator with strong follow-up skills and timely escalation of issues.
• Experience in therapeutic areas like oncology, immunology, or respiratory conditions is a plus.
• Willingness to travel up to 20% domestically or internationally as required by study needs.

Company Overview

Generate Biomedicines is an innovative clinical-stage company pioneering AI-driven protein design and drug development. Founded in 2018, the company integrates machine learning with extensive experimentation to streamline the creation of protein-based medicines, advancing multiple clinical and preclinical programs in diverse disease areas.

The organization values collaborative innovation across disciplines to accelerate the delivery of enhanced medicines to patients, guided by a commitment to equality and diversity.

Equal Employment Opportunity

Generate Biomedicines is an equal opportunity employer welcoming applicants regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status.

Recruitment Policy

Unsolicited resumes from staffing or recruitment agencies are not accepted unless initiated by the internal Talent Acquisition team. Any unsolicited submissions become the property of Generate Biomedicines and no fees will be paid.

Compensation

The expected base salary range is $127,000 to $178,000 annually, determined by skills, experience, education, and market factors. Additional benefits include an annual bonus, equity awards, and a competitive benefits package.