Sr. Clinical Trial Manager

City Therapeutics•Cambridge, MA

6d•Onsite

About The Position

City Therapeutics is seeking a Senior Clinical Trial Manager to lead cross-functional Clinical Study Teams and plan and manage the operational aspects of assigned clinical trials. The role provides strategic direction and operational oversight from study endorsement and start-up through execution, close-out, and reporting. The Sr. CTM partners with internal stakeholders, CROs, investigators, clinical sites, and external vendors to deliver trials on time and within budget while ensuring quality and compliance with ICH-GCP and regulatory requirements. The trials may range from Phase 1 dose-escalation studies to later-phase global clinical trials. This is a full-time onsite opportunity with travel of up to 15%, including international travel. The position contributes to clinical trial strategy and oversees study timelines, budgets, vendors, CROs, documentation, financial performance, risk management, and inspection readiness. The role also supports clinical operations process improvement and departmental strategic initiatives.

Requirements

Bachelor's degree in a life sciences or healthcare-related discipline.
At least 5 years of clinical trial management experience in the biotechnology or pharmaceutical industry.
Strong project management skills and a proactive, solutions-oriented mindset.
Excellent interpersonal, communication, and organizational skills.
Proven ability to manage vendors and CROs and drive accountability and high-quality deliverables.
Deep knowledge of clinical trial regulations and guidelines, including ICH-GCP, FDA, and EMA requirements.
Ability to work independently and collaboratively in a dynamic, cross-functional team environment.
Willingness to travel up to 15%, including internationally.

Nice To Haves

Advanced degree.

Responsibilities

Plan and manage clinical trial operations across the study lifecycle, including start-up, execution and maintenance, close-out, and reporting, aligning milestones and deliverables with the Clinical Development Plan and company goals.
Lead cross-functional clinical study teams and serve as the primary contact for trial-related activities and updates to internal leadership.
Ensure study contributions, execution, and delivery meet quality, plan, timeline, and budget expectations.
Contribute to trial strategy, including protocol development, country and site selection, vendor identification, risk management, and study timeline and budget development.
Review final drafts and approve key study documents, including informed consent forms, study management plans, submission packages, GDPR compliance materials, and annual reports.
Build and maintain professional relationships with vendors and CROs, overseeing performance, tracking deliverables, and escalating and resolving issues.
Partner with investigators, site staff, external partners, and internal stakeholders to support study execution, enrollment, and delivery targets.
Identify and proactively manage study risks, mitigation strategies, and escalations.
Ensure operational compliance with GCP, SOPs, and regulatory requirements.
Champion inspection readiness and support audits and regulatory inspections, including CAPA development.
Lead study-level budgeting and site contracting with legal and finance teams.
Monitor vendor financial performance and review invoices, change orders, and scopes of work.
Oversee CRO management of the Trial Master File (TMF), ensuring completeness and quality.
Ensure timely and accurate clinical trial registration and updates in registries such as ClinicalTrials.gov.
Identify and implement clinical operations process improvements and efficiency opportunities.
Contribute to departmental goals and strategic initiatives.