Clinical Trial Manager

About the Role

Generate Biomedicines is looking for a diligent and proactive Clinical Trial Manager (CTM) to oversee the operational facets of late-stage clinical trials within the Clinical Development team. Reporting directly to the Director of Clinical Operations, the CTM will act as the primary day-to-day coordinator for specified studies, ensuring smooth collaboration with CROs and specialized vendors who execute clinical trial operations.

This position plays a vital role in monitoring external partners' deliverables, promptly identifying any issues, coordinating internal teams, and escalating concerns to clinical operations leadership when necessary. It presents a strong growth opportunity for professionals eager to advance their clinical operations career on the sponsor side.

Key Responsibilities

• Act as the daily operational liaison for assigned CROs and vendors, monitoring study timelines and deliverables, and communicating risks or delays to leadership.
• Review study documents prepared by CROs, including monitoring visit reports, site communications, protocol deviations, and Trial Master File (TMF) documentation, ensuring accuracy and completeness.
• Assist with study initiation activities such as site activation tracking, gathering regulatory documents, and preparing vendor kick-off meetings.
• Maintain comprehensive study trackers, timelines, and action logs to ensure all cross-functional teams remain informed about study progress and pending tasks.
• Participate in cross-functional study meetings, document minutes, track action items, and ensure follow-up on deliverables.
• Manage reported protocol deviations by collaborating with CROs and internal stakeholders to ensure proper documentation and resolution.
• Coordinate safety reporting tasks, including tracking Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR), ensuring timely communication with sites and relevant parties as per vendor responsibilities.
• Oversee TMF completeness and support audit readiness by working with CROs to resolve gaps and uphold document quality standards.
• Support Institutional Review Board (IRB)/Independent Ethics Committee (IEC) tracking at study sites, monitoring approval statuses for amendments and renewals submitted by CROs.
• Compile and provide regular updates on enrollment, site performance, and operational metrics to clinical operations leadership.
• Assist in data quality reviews and oversee data cleaning progress conducted by CROs.
• Evaluate monitoring visits and associated reports from CROs to confirm quality and adherence to monitoring plans.
• Support invoice review and budget management by comparing CRO invoices to contracted activities and flagging inconsistencies.
• Coordinate data reconciliation efforts at critical study milestones alongside data management teams and CRO partners.
• Facilitate onboarding of Clinical Trial Assistants (CTAs) joining study teams and serve as a daily resource for study-related inquiries.

Candidate Profile

• Possess a Bachelor’s degree, preferably in a scientific or health-related subject.
• Bring over six years of experience in clinical operations, clinical research, or related areas; experience from the sponsor side is advantageous.
• Understand fundamental Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and clinical trial standards.
• Have experience coordinating or supporting roles working with CROs or clinical vendors.
• Exhibit strong organizational skills, capable of handling multiple trackers, timelines, and action items effectively.
• Be comfortable in a vendor-managed operational model, focusing on oversight and coordination rather than direct execution.
• Familiarity with clinical trial management systems such as CTMS, electronic data capture (EDC), and electronic Trial Master File (eTMF) platforms is expected.
• Demonstrate excellent communication skills with the ability to follow up consistently and escalate issues timely.
• Knowledge of therapeutic areas including oncology, immunology, and respiratory diseases is a beneficial addition.
• Willingness to travel up to 20% domestically or internationally based on study requirements.

About Generate Biomedicines

Generate Biomedicines is a clinical-stage company innovating the drug development process through AI-driven protein design. Founded in 2018, the company integrates machine learning with large-scale experimentation to streamline protein-based medicine development, focusing on multiple disease areas. Their approach merges computational design with clinical development, transitioning the drug discovery paradigm towards systematic drug generation.

The company values interdisciplinary collaboration and diversity to accelerate the delivery of improved medicines to patients globally. Generate Biomedicines is an equal opportunity employer, ensuring inclusive hiring regardless of race, color, religion, gender, or veteran status.

Additional Information

Recruitment agencies are not authorized to submit resumes without prior company contact and agreement. Any unsolicited resumes sent will become company property without incurring referral fees.

Compensation Details

The anticipated annual base salary ranges from $127,000 to $178,000 USD, dependent on factors such as skills, experience, education, and market conditions. Eligible candidates will also receive annual bonuses, equity awards, and competitive benefits packages.