Sr. Clinical Trial Manager

City Therapeutics•Cambridge, MA

7d•$164,000 - $185,000•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 Senior Clinical Trial Manager partners with internal stakeholders, CROs, investigators, clinical sites, and external vendors to deliver trials ranging from Phase 1 dose-escalation studies through later-phase global trials on time and within budget, in compliance with ICH-GCP and regulatory requirements. This is a full-time onsite opportunity.

Requirements

Bachelor's degree in a life sciences or healthcare-related discipline.
At least 5 years of clinical trial management experience within the biotech 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, driving 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

An advanced degree.

Responsibilities

Plan and manage clinical trials throughout their lifecycle, ensuring milestones, objectives, and deliverables align 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 activities and updates to internal leadership.
Ensure clinical studies are delivered according to quality requirements, plans, timelines, and budgets.
Contribute to clinical trial strategy, including 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, including informed consent forms, study management plans, submission packages, GDPR compliance materials, and annual reports.
Manage relationships and performance with vendors and CROs through oversight plans, performance tracking, and issue escalation and resolution.
Build partnerships with investigators, site staff, external partners, and internal stakeholders to support efficient study execution and enrollment and delivery targets.
Identify and manage study risks, develop mitigation strategies, and escalate issues appropriately.
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 registry registration and updates, including in ClinicalTrials.gov.
Identify and implement clinical operations process improvements and contribute to departmental goals and strategic initiatives.