Lead Clinical Trial Manager - OCORO

Prolaio • Chicago, IL

3d • $141,000

About The Position

The Lead Clinical Trial Manager for the OCORO Study is crucial to the success of the program and for the organization. The Operations Department is responsible for the end-to-end operational success of Prolaio’s OCORO Study (OCORO). In partnership with other cross-functional team members, this role ensures OCORO proceeds according to strategic aims and that the study conforms to applicable ICH/GCP, SOPs, company policies, timelines and budget, and regulatory guidelines to provide timely delivery of high-quality clinical data to support high-impact publication and further registration and commercialization of Prolaio products that may emerge from OCORO.
The position will translate strategy into trial leadership and own the implementation of Prolaio systems in studies, including leading the protocol team with minimal oversight. The position will be responsible for executing one more protocol derived from OCORO.

Requirements

• 7-10 years of industry relevant experience.
• Bachelor’s degree or nursing equivalent; master’s degree in a clinical discipline a plus.
• Experience leading and collaborating with a variety of cross-functional stakeholders, including device management and engineering staff, management, and vendors (both clinical and technical) during the creation and implementation of systems.
• Ability to identify and suggest improvements in technical and development systems within the organization.
• Lead at a first-line management level within a growing organization.
• Experience with data flow visualization tools, TMF systems, and/or other validated software.
• Thorough knowledge of EMA and/or FDA regulations (or relevant local regulations), ICH guidelines, GCP governing the conduct of clinical studies, and device regulations such as ISO13485.
• Knowledge of Google Suite tools and email systems. Ability to learn/oversee non-standardized systems.
• Must be able to translate strategy into action, develop and mentor teams, work in a small startup environment, and build from ideas to create near- and long-term fit-for-purpose structure.
• Ability to effectively communicate with a wide range of audiences, including articulating technical concepts to a non-technical audience.

Responsibilities

• Manage the OCORO program to meet strategic aims set by Executive Committee and oversee all OCORO KPIs
• Perform as single point of contact and primary liaison with CROs, vendors, investigators, and study coordinators, ensuring effective collaboration and compliance with protocol requirements as well as to resolve operational challenges.
• Envisage and galvanize strategies to promote study enrollment to secure study data that will inform high-impact publications and clinical workflows.
• Ensure that the OCORO study is conducted according to protocol CTP-030 objectives, including data collection according to the OCORO Schedule Events.
• Oversee and own the audit-readiness of the OCORO Trial Master File and all Essential Documents pursuant to ICH E6(R2) using document control systems established by Prolaio (e.g., Ostendio MyVCM).
• In concert with the Prolaio Production and Quality teams, ensures the OCORO kit inventory meets study demands and that kits are deployed according to 21CFR820 Quality Management System Regulation and ISO13485 Quality Management Systems requirements
• Understand, interpret, and explain protocol requirements to others. Build training materials for cross-functional partners.
• Coordinate review of data and preparation of interim/final agency filings and clinical reports; interface with clinical data management, engineering, and other groups for data prioritization and quality.
• Develop RFPs, secure purchase orders and lead in selection of CROs/vendors and other functional service providers; assist in CRO and vendor interface, relationship management, and collaboration to communicate requirements as it pertains to study priorities.
• Lead the training and oversight of CROs, investigators, study coordinators, and vendors on study requirements.
• Contribute to projection, development and tracking of study budget and accounting reviews.
• Functional expertise to support SOP or operational workflow development and implementation.
• Assist in supply management, clinical supply oversight, IRT coordination, and implementation.
• Act as a subject matter expert in a health authority, vendor, or internal audit where applicable.
• Lead oversight and implementation for the Trial Master File (TMF) and related activities. Ensure all essential documentation is included in the established Document Control system.
• Ability to monitor, act as an in-house site oversight.
• Comply with the expectations of the Quality Management System (QMS), including Biosketch forms, job descriptions, training, etc.

Benefits

• Meaningful Compensation: Competitive salary, performance bonus, and equity so you can share in what we build.
• Great Health Coverage: Medical, dental, and vision plans with multiple options and strong company contributions.
• Flexible Spending Perks: HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
• Time to Recharge: Generous paid time off, sick leave, and company holidays.
• Family-First Benefits: Paid parental leave, caregiver leave, and support for growing families.
• Security & Peace of Mind: Company-paid life insurance and short- and long-term disability coverage.
• Plan for the Future: 401(k) plan to help you build long-term financial security.
• Care When You Need It: Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager