City Therapeutics

CTM/ Sr. Clinical Trial Manager

Cambridge, MA · Senior · Full-time

Sponsorship not specified$164k-$185kDetected 30 days ago

GCPComplianceProject ManagementBudgetingClinical TrialsFDA RegulatoryLeadershipCommunication

About the role

In this role, you will serve as the primary point of contact for study leadership, providing strategic direction and operational oversight from study start-up through close-out.
Monitor vendor 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.
Contribute to departmental goals and strategic initiatives.

Lead cross-functional teams throughout the lifecycle of clinical trials, including start-up, execution, and close-out. Serve as the primary contact for study-related activities and updates to internal leadership.
Lead or support the development of protocols, amendments, clinical study reports, and related documents.
Lead the study-level budgeting and site contracting process, in partnership with legal and finance teams. Monitor vendor performance and review invoices, change orders, and scopes of work to ensure financial accountability.
Identify and implement opportunities to improve clinical operations processes and drive efficiency. Contribute to departmental goals and strategic initiatives.
Identify and proactively manage study risks with mitigation strategies and appropriate escalation.
Champion inspection readiness and support audits and regulatory inspections, including CAPA development.
CTM) to lead the cross-functional Clinical Study Team and ensure successful delivery of assigned clinical studies.
You will partner closely with internal stakeholders, CROs, and external vendors to deliver global clinical trials on time and within budget, ensuring quality and compliance with ICH-GCP and regulatory requirements.

Minimum of 6 years of experience in clinical trial management within biotech or pharmaceutical industry.
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.
Bachelor's degree in a life sciences or healthcare-related discipline (advanced degree a plus).
Proven ability to manage vendors and CROs, driving accountability and high-quality deliverables.
Strong project management skills with a proactive, solutions-oriented mindset.
Excellent interpersonal, communication, and organizational skills.
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.

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.
Per Year Salary Range: $164,000 to $185,000
national origin
marital, domestic partnership or civil union status

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
City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce.

This listing is sourced directly from City Therapeutics's careers page and normalized into a canonical job model.