Clinical Trial Manager (Oncology)

Tyra Biosciences; United States; Hybrid; USD 148,000 - 163,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) match 1:1 up to 4%

Employee Stock Purchase Plan

Paid holidays

Parental leave

Wellness program

Job summary

Tyra Biosciences is seeking a Clinical Trial Manager to lead the UTUC trial from startup to close-out. You will manage CROs, vendors, and sites, ensuring milestones, budgets, and regulatory requirements are met, while partnering with internal teams.

The role emphasizes trial start-up, regulatory submissions, TMF integrity, and inspection readiness, with remote flexibility and periodic in-person collaboration across the United States.

Qualifications

• Bachelor’s degree in life sciences or related field with clinical trial knowledge.
• Experience in managing CROs, vendors, and study sites under GCP.
• Familiarity with TMF processes, regulatory submissions and audits.

Responsibilities

• Oversee CROs, study vendors and clinical trial sites to ensure on-time delivery.
• Support protocol development, site setup, regulatory submissions and manuals.
• Maintain study files and ensure proper archiving and inspection readiness.
• Coordinate cross-functional activities and budget management.
• Lead TMF reviews and ensure data quality across study components.
• Assist with CSR completion and regulatory submissions and audits.
• Communicate with trial teams, asset leads and CRO partners.

Skills

CRO management

Vendor coordination

Budget management

GCP compliance

TMF reviews

Regulatory submissions

Education

Bachelor's degree in life sciences

Tools

CTMS

IRT systems

Job description

The Clinical Trial Manager will play a key contributor role in the strategic implementation and execution of the UTUC clinical trial from study start up to close-out. The position is responsible for the management and oversight of CRO’s, study vendors and clinical trial sites, and will partner with key internal stakeholders to ensure clinical trial deliverables are completed on-time, within budget, and in accordance with regulatory requirements, GCP guidelines and internal SOPs.

Essential Functions And Responsibilities

• Support the clinical operations team in the successful execution of the UTUC clinical trial from protocol concept to clinical study report
• Assist in UTUC study set‐up including but not limited to protocol/synopsis preparation, informed consent form preparation and review, systems (i.e., CTMS, IRT, ), and regulatory submissions, study operational manuals, training manuals, investigator document review, various study plans (i.e., visit logs, drug inventory, monitoring plans, etc.), and other study‐related requests
• Prepare and maintain study related files
• Organize study and departmental meetings, take minutes, and ensure all study documentation is appropriately archived
• Coordinate clinical trial equipment and supplies
• Coordinate cross‐functional project related activities (e.g., Clinical Data Review Meetings)
• Ensure clinical team compliance with all required study specific training
• Perform TMF reviews to ensure completeness
• Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections
• Assist with budget management
• Support the day‐to‐day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines and other regulatory requirements
• Activities may include tracking of appropriate subject and site activity/metrics, performing quality check activities across components of the clinical study, and other related activities
• Proactively identify and escal… issues that arise related to support functional deliverables
• Collaborate with CRO on the timely collection and archiving of TMF documents for assigned studies/programs
• Coordinate with regulatory affairs on the ongoing submission of essential documents to regulatory authorities
• Assist in the management of study completion activities with the CRO and the sites including TMF reconciliation, drug reconciliation, ensure that all documents are available for the CSR
• Effectively communicate with study team members and work closely with Clinical Trial Managers and/or Asset Leads
• May participate in process improvement and quality‑related initiatives associated with study execution and deliverables.
• Work to ensure the achievement of study timelines including FPI, enrollment targets, site activation, and data cleaning goals.

Pay Range and Benefits:

Base Salary Range: $148,304 - $162,985 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer -paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit

Job Type: Full-Time

Work Location: Remote flexibility with periodic in-person collaboration

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.