[Hiring] Senior Clinical Trial Manager @Kriya Therapeutics

Role Description

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.

Qualifications

• 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.

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!