Senior Clinical Trial Manager

Kriya Therapeutics; United States; Remote; USD 130,000 - 190,000; Full time

Benefits offered by this job

Flexible Time Off

Health Insurance

Equity

401(k) Matching

Life Insurance

Job summary

Kriya Therapeutics, Inc. is seeking a Senior Clinical Trial Manager to lead day-to-day operations of clinical trials, oversee CROs and vendors, and ensure trials meet ICH/GCP and SOP standards. This remote, US-based role requires strong cross-functional collaboration and budget stewardship.

Responsibilities include start-up activities, protocol input on operational aspects, and milestone reporting. Travel may be required to sites and conferences as needed.

Qualifications

• Minimum 6+ years in pharma/biotech with 4+ years clinical trials management.
• Ophthalmology experience highly preferred.
• Experience managing external suppliers or virtual teams (CROs/independent contractors).
• Budget and contract negotiation experience.

Responsibilities

• Oversee day-to-day management of clinical trials, vendors, and sites.
• Lead start-up, conduct, and close-out activities for studies.
• Develop study budgets and negotiate contracts with vendors.
• Create and amend informed consent forms and trial documents.
• Ensure compliance with SOPs, ICH/GCP and regulatory guidelines.
• Coordinate with CROs and external vendors for milestones and timelines.
• Provide regular study status updates to program management.

Skills

Clinical Trials Management

Vendor Management

Budget Negotiation

EDC/CTMS/IRT

Cross-functional Leadership

Communication

Regulatory Knowledge

Independent Work

Education

BS or equivalent

Tools

EDC

CTMS

IRT

UAT

Job description

Senior Clinical Trial Manager

Department: Clinical

Employment Type: Full Time

Location: Remote

Description

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Role Overview

The Senior Manager, Clinical Trials Management is responsible for the day-to-day management of clinical trials, vendors, and clinical trial sites, and works closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, timelines, and budgets.

Key Responsibilities

• Is part of the team ensuring clinical operational oversight for assigned project/studies to ensure they are conducted in accordance with internal SOPs and ICH/GCP requirements.
• Participate in the preparation of study budgets; negotiation of contracts and vendors; supports invoice review through payment.
• Lead operational activities as they relate to study-level start-up, conduct and close-out.
• Assist with the development of clinical protocols as they relate to the operational aspects of the trial.
• Manage and serve as a point of contact for the CRO and other clinical vendors on a study
• Lead the creation and amending of informed consent forms, source documents, and other documents, manuals and plans related to a clinical trial.
• Participate in the development, maintenance and reporting of clinical project milestones and timelines.
• Participate in the selection of CROs, clinical vendors, and other consultants.
• Create a partnership with CRO and other key vendors.
• Establish relationships with PIs and clinical site staff and, in conjunction with the CRO, ensure they are compliant with protocols and overall clinical objectives and deliverables.
• Lead cross-functional internal study team meetings.
• Work with project management to keep the project plan current and managed to critical path. Provide regular study status updates including critical issues to Program level management as needed.
• Escalates performance issues with CRO and other key vendors in a timely fashion.
• Collaborate with the Quality Assurance (QA) team to stay abreast of new and/or evolving local regulations, guidelines, and policies.
• Perform other related duties as required to support the Clinical Operations Team and company goals.
• Assist with the development of operational SOPs and processes and contributes to the design of operational excellence activities including study and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials.

Experience & Skills and Work Environment

Experience & Skills

• BS or equivalent
• A minimum 6+ years experience in the pharma/biotech industry with a minimum of at least 4 years direct clinical trials management experience.
• Ophthalmology experience highly preferred.
• Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors).
• Previous clinical trial management or project management experience with demonstrated leadership ability.
• Experience with Electronic Data Capture (EDC), CTMS, IRT systems; UAT experience desirable.
• Excellent communication; interpersonal skills and influencing skills.
• Ability to determine the resources and support to meet project goals and timelines.
• Previous budget and contract negotiation experience.
• Knowledge of ICH/Good Clinical Practices (GCP)
• Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs.
• Able to work in a fast-paced environment and effectively multi-task.
• Able to work independently.
• Excellent time management skills (timelines, schedules, task prioritization).
• Willing and able to travel, including within the U.S. and internationally
• Proficiency using Microsoft Outlook, Word, PowerPoint, and Excel.
• Experience with gene therapy & ophthalmology is preferred but not required.

Work Environment

• Primarily desk-based, generally in an office or home office setting.
• Involves extended periods of sitting and computer use.
• Occasional travel may be required.
• Possibility of working outside of normal scheduled hours.

Life at Kriya

Discover True Collaborative Teamwork

We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.

We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

Rewards & Benefits

• Time Off & Work-Life Balance: Flexible Time Off Paid Parental & Medical Leave Paid Company Holidays
• Health & Wellness: Fertility & Family Building Benefits Medical, Dental, and Vision Insurance Employee Assistance Program (EAP) Life Insurance Short- and Long-Term Disability Coverage
• Financial Security:Equity 401(k) with Company Match Identity Theft Protection
• And More!