Senior Clinical Trial Manager

Kriya Therapeutics•Remote, NC

4d•Remote

About The Position

Kriya is a biopharmaceutical company developing gene therapies for diseases with high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. The Senior Clinical Trial Manager is responsible for the day-to-day management of clinical trials, vendors, and clinical trial sites. The role works closely with cross-functional teams to ensure trials comply with SOPs, ICH/GCP and country-specific regulatory guidelines, company goals, timelines, and budgets.

Requirements

Bachelor of Science degree or equivalent.
At least 6 years of experience in the pharmaceutical or biotechnology industry, including at least 4 years of direct clinical trials management experience.
Experience managing external suppliers and/or working in a virtual environment, such as with CROs and independent contractors.
Previous clinical trial management or project management experience with demonstrated leadership ability.
Experience with Electronic Data Capture (EDC), CTMS, and IRT systems.
Excellent communication, interpersonal, and influencing skills.
Ability to determine the resources and support needed to meet project goals and timelines.
Previous budget and contract negotiation experience.
Knowledge of ICH/Good Clinical Practices (GCP).
Ability to use personal expertise and input from others to identify issues and make recommendations that address corporate and program needs.
Ability to work in a fast-paced environment, multitask effectively, and work independently.
Excellent time management skills, including managing timelines, schedules, and task priorities.
Willingness and ability to travel, including within the U.S. and internationally.
Proficiency with Microsoft Outlook, Word, PowerPoint, and Excel.

Nice To Haves

Ophthalmology experience is highly preferred.
User acceptance testing (UAT) experience is desirable.
Gene therapy and ophthalmology experience is preferred but not required.

Responsibilities

Provide clinical operational oversight for assigned projects and studies to ensure compliance with internal SOPs and ICH/GCP requirements.
Participate in preparing study budgets, negotiating contracts and vendor arrangements, and supporting invoice review through payment.
Lead study-level operational activities for start-up, conduct, and close-out.
Assist with developing clinical protocols, particularly their operational aspects.
Manage and serve as the point of contact for CROs and other clinical vendors on a study.
Lead the creation and amendment of informed consent forms, source documents, and other clinical trial documents, manuals, and plans.
Participate in developing, maintaining, and reporting clinical project milestones and timelines.
Participate in selecting CROs, clinical vendors, and other consultants.
Build partnerships with CROs and other key vendors.
Establish relationships with principal investigators and clinical site staff and, with the CRO, ensure compliance with protocols and clinical objectives and deliverables.
Lead cross-functional internal study team meetings.
Work with project management to keep the project plan current and managed to the critical path; provide study status updates and critical issues to program-level management as needed.
Escalate CRO and other key vendor performance issues in a timely manner.
Collaborate with Quality Assurance to stay current on evolving local regulations, guidelines, and policies.
Perform other related duties to support the Clinical Operations Team and company goals.
Assist with developing operational SOPs and processes and contribute to operational excellence initiatives, including study and trial metrics, communication platforms, and process improvements.