Clinical Study Manager

A Trusted CRO Partner for the Future of Eye Care

iuvo Clinical is a full-service ophthalmology-focused contract research organization (CRO) dedicated to improving patient’s quality of life with breakthrough eyecare therapies. We combine decades of specialized experience with a high touch, high science approach, partnering with innovators to accelerate ophthalmic breakthroughs from concept to commercialization. Whether advancing a novel retinal therapy or supporting a complex ocular device trial, we provide the expertise, flexibility, and personal dedication to ensure clinical trial success.

We offer a comprehensive benefits package and the opportunity to broaden your experience and grow your career!

We currently have an opportunity for a Clinical Study Manager to join our Clinical team.

The Clinical Study Manager (CSM) works in collaboration with the Project Manager and Sponsor on the strategy, planning, and successful execution of clinical programs. The CSM partners with other internal and external parties to ensure clinical trial activities and deliverables are completed on time and within budget.

As a member of the Clinical team, the Study Manager is responsible for assigned clinical programs including, but not limited to, oversight of key project deliverables, resources, including CRA team, timelines, clinical trial site logistics and communications in the most cost and time effective way, while assuring quality and GCP compliance.

The Study Manager takes accountability for operational aspects of assigned clinical study/ies and assumes varied levels of responsibility for study budget tracking, training of both CRO and site staff and the management of activities conducted by contract CRAs. The Study Manager also ensures trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.

• Support and/or lead the administration, coordination and management of study activities across multiple functional groups.
• Coordinate clinical study timelines with Project Management to meet critical milestones and Sponsor corporate goals;
  escalate issues that may jeopardize timelines and deliverables.
• Conduct and implement required internal and site training; coordinate operational and therapeutic area training by Medical Monitor for internal study team members.
• Participate in study planning and set-up activities including vendor management, project management and the coordination of study and implementation plans.
• Oversee site identification feasibility, evaluation and selection.
• Review CRA site visit reports and take action as required with Sponsor and/or sites; provide input into EDC/eCRF design and user acceptance testing as needed.
• Manage relationship with the sponsor, CRO, investigative site staff, laboratory, pharmacy and other internal and external personnel as applicable.
• Review study documentation for accuracy, completeness and turnaround times; solicit information to support inquiries.
• Participate in protocol review and provide input as needed.
• Create and implement study-specific plans and templates, clinical monitoring plans and report templates, and monitoring tools and documents.
• Monitor site subject recruitment activities and report progress to PM and/or project team; create investigator meeting training material and participate in the presentation of IM material, participate in the planning of offsite meetings.
• Monitor the progress of studies, data flow, identifying study related trends/issues and work with Project Management to implement corrective actions when necessary.
• Provide regular updates of study progression to Project Manager and executive management.
• Develop site-facing materials as needed including logs, source documents/worksheets/checklists, study newsletters, presentations, etc.
• Create and maintain FAQ/Decision Logs.
• Work with other team members and sites to create and execute recruitment plans in order to meet or exceed enrollment timelines.
• Manage the tracking and forecasting of key study metrics and deliverables.
• Develop tables, spreadsheets, charts and/or graphs for use on project calls.
• Work with the Finance department to review site payment reports for accuracy.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability…