Clinical Trial Manager/ Sr. Clinical Trial Manager

City Therapeutics•Cambridge, MA

1d•$164,000 - $185,000•Onsite

About The Position

At City Tx, we’re building the next generation of siRNA medicines—and a team bold enough to redefine what RNA therapeutics can do. We are pushing the science further and translating breakthrough ideas into meaningful medicines for patients. We’re looking for curiosity, and a willingness to roll up your sleeves and contribute wherever you can make an impact. We are looking for people who embrace ambitious challenges, move with purpose, collaborate generously, and are excited to help build both breakthrough medicines and an exceptional company. If you’re energized by ambitious science, meaningful problems, and the opportunity to build something from the ground up, we’d love to hear from you. We are seeking a motivated Clinical Trial Manager / Senior Clinical Trial Manager (CTM/Sr. CTM) to lead the cross-functional Clinical Study Team, plan and manage the operational aspects of assigned clinical trials ensuring their successful delivery. In this role, you will serve as the primary point of contact for study leadership, providing strategic direction and operational oversight from endorsement and start-up through execution, close-out, and reporting. You will partner closely with internal stakeholders, CROs, Investigators/clinical sites and external vendors to deliver Phase 1 dose-escalation through later-phase global clinical trials on time and within budget, ensuring quality and compliance with ICH-GCP and regulatory requirements.

Requirements

Bachelor's degree in a life sciences or healthcare-related discipline (advanced degree a plus).
Minimum of 6 years of experience in clinical trial management within biotech or pharmaceutical industry.
Strong project management skills with a proactive, solutions-oriented mindset.
Excellent interpersonal, communication, and organizational skills.
Proven ability to manage vendors and CROs, driving accountability and high-quality deliverables.
Deep knowledge of clinical trial regulations and guidelines (ICH-GCP, FDA, EMA, etc.).
Ability to work independently and collaboratively in a dynamic, cross-functional team environment.
Willingness to travel up to 15%, including international travel.

Responsibilities

Plan and manage the operational aspects of clinical trials throughout the trial’s lifecycle (study start-up, execution and maintenance, close-out, and reporting), ensuring that milestones, objectives, and deliverables are aligned with the Clinical Development Plan and program and company goals.
Lead cross-functional clinical study teams and serve as the primary point of contact for trial-related activities and updates to internal leadership.
Contribute to clinical trial strategy, including supporting protocol development, country and site selection, vendor identification, risk management, and development of study timelines and budgets.
Oversee the development and maintenance of key study documents such as informed consent forms, study management plans, submission packages, GDPR compliance materials, and annual reports.
Drive vendor and CRO performance through oversight plans, performance tracking, and issue resolution.
Foster strong partnerships with investigators, site staff, external partners and internal stakeholders to support efficient study execution and achievement of enrollment and delivery targets.
Identify and proactively manage study risks with mitigation strategies and appropriate escalation. Ensure compliance with GCP, SOPs, and regulatory requirements across all operational activities. Champion inspection readiness and support audits and regulatory inspections, including CAPA development.
Lead the study-level budgeting and site contracting process, in partnership with legal and finance teams. Monitor vendor financial performance and review invoices, change orders, and scopes of work to ensure financial accountability.
Oversee CRO management of the Trial Master File (TMF), ensuring completeness and quality. Ensure timely and accurate registration and updates in clinical trial registries (e.g., ClinicalTrials.gov).
Identify and implement opportunities to improve clinical operations processes and drive efficiency. Contribute to departmental goals and strategic initiatives.