Sr. Clinical Trial Manager, Clinical OperationsWe 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 opportunityResponsibilities: - 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 and serve 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
