Clinical Trial Manager/ Sr. Clinical Trial Manager

Clinical Trial Manager/ Sr. Clinical Trial Manager

Cambridge, Massachusetts, United States

At City Tx, we're building the next generation of siRNA medicinesand 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.

This is a full-time onsite opportunity

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.

Qualifications:

• 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.

City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment Agency inquiries or submissions will not be accepted at this time.

Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including relevant skills, experience, internal equity, relevant education or training and market dynamics. In addition, this role is eligible for an annual cash bonus and equity compensation. City Therapeutics offers a comprehensive and competitive benefits package including medical, dental, vision, life insurance, health and dependent care FSA accounts, HSA/HRA accounts with company contributions, in addition to a 401(k) with competitive company match. Per Year Salary Range: $164,000 to $185,000

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.