Sr. Clinical Trial Manager

City Therapeutics; Cambridge (MA); On-site; USD 164,000 - 185,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Life insurance

HSA/FSA accounts

401(k) with company match

Job summary

City Therapeutics is seeking a Senior Clinical Trial Manager to lead cross‑functional teams and manage the operational delivery of Phase 1 dose‑escalation through later‑phase trials. You will coordinate with CROs, investigators, and internal stakeholders to ensure quality, timelines, and budget adherence in a fast‑paced biotech environment.

You will partner with legal and finance on budgeting and contracting, oversee TMF and trial registries, and drive inspection readiness while maintaining

Qualifications

• Minimum of 5+ years of experience in clinical trial management or biotech/pharma industry.
• Strong project management and proactive problem-solving skills.
• Excellent interpersonal, communication, and organizational abilities.
• Deep knowledge of clinical trial regulations (ICH-GCP, FDA, EMA).

Responsibilities

• Plan and manage operational aspects of clinical trials from start-up to close-out.
• Lead cross-functional study teams and coordinate updates to internal leadership.
• Support protocol development, site and country selection, vendor identification, and budgeting.
• Review and approve key study documents (informed consent, study management plans, reports).
• Maintain relationships with vendors and CROs and monitor performance and issues.
• Manage study risks, ensure GCP compliance, and support inspections and CAPAs.
• Oversee budgeting and site contracting with legal and finance teams and monitor invoices.
• Ensure TMF completeness and timely trial registry updates (e.g., ClinicalTrials.gov).
• Identify process improvements to drive efficiency and align with strategic goals.

Skills

Project management

Cross-functional leadership

Communication

Vendor management

Regulatory knowledge

Education

Bachelor's degree in life sciences

Tools

TMF management

Job description

Sr. Clinical Trial Manager, Clinical Operations

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 science further and translating breakthrough ideas into meaningful medicines for patients.

We’re looking for curiosity, flexibility 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. Ifyou’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 Senior Clinical Trial Manager (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:

• Accountable for planning and managing 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 andserve as the primary point of contact for trial-related activities and updates to internal leadership. Ensuring effective contribution, execution and delivery of clinical study as per quality, plan/timelines, budget.
• Contribute to clinical trial strategy, including supporting protocol development, country and site selection, vendor identification, risk management, and development of study timelines and budgets.
• Review final drafts and approve key study documents such as informed consent forms, study management plans, submission packages, GDPR compliance materials, and annual reports.
• Establish and maintain excellent professional relationships with vendors and CROs, ensuring strong performance through oversight plans, performance tracking, and issue escalation and 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 5+ 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 Affinitive 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.