Senior Clinical Trial Manager

Department: Clinical

Employment Type: Full Time

Location: Remote

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 Bio Space’s “2025 Best Places to Work.”

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.

• 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.

• 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…