Clinical Study Management and Operations

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• Conducting in-depth study scoping, literature reviews, and stakeholder alignment through cross-functional discussions.
• Crafting robust study charters and detailed project plans.
• Designing study protocols and clinical investigation plans. 
• Study endpoint development and prioritization.
• Collaborating with biostatistics for sample size determination and statistical analysis development.
• Creating and refining all study documents, including data management plans, monitoring plans, training plans, DSMP, investigator brochures, and more.
• Designing subject-facing documents such as informed consent forms and recruitment brochures/flyers.
• Managing revisions and peer review of existing documents.
• Designing data collection tools, including CRFs, CCGs, data entry guidelines, source worksheets, and subject surveys/questionnaires.
• Conducting rigorous database and CRF testing.
• Developing essential study tools such as trial master files, screening/enrollment trackers, budget forecast/actuals trackers, monitoring trackers, and more .
• Leading contract/budget development and negotiation with sites and vendors.
• Conducting vendor feasibility and selection processes.
• Obtaining central IRB/EC approval.

• Developing site identification strategy and site selection criteria.
• Creating site communication templates and site feasibility questionnaires.
• Conducting site qualification visits and preparing corresponding reports.
• Nominating and selecting sites.
• Obtaining local IRB/EC approvals.

• Optimizing study startup with training materials and initiation visits/activities/reports.
• Providing training/mentoring for sponsor teams, monitors, site investigators, and coordinators.
• Planning and tracking device shipment and accountability.
• Overseeing and performing site level management 
• Providing vendor management and oversight.
• Communicating with sponsors, sites, and vendors regarding study progress, challenges, risks, and priorities.
• Planning and overseeing monitoring activities, interim monitoring report reviews, and risk/resource management.
• Conducting periodic data listing reviews and managing regulatory milestones.
• Conducting Investigator, CRA, and CRC trainings and meetings.
• Managing ClinicalTrials.gov registration and management.
• Managing AE/safety reporting and potential complaints requirements. 
• Preparing FDA annual reports.

• Conducting final data listing reviews, cleaning, and analysis.
• Facilitating collaboration for investigator and other stakeholder input.
• Preparing study reports, conference abstracts, manuscripts, and presentations.
• Managing site closeouts.

A med device company struggled with the full market launch of an acquired device, despite substantial investments in acquisition and product enhancement. Known limitations from benchmark testing cast doubt on acceptance by clinicians, and two pilot projects and a Beta initiative, aimed at gathering a comprehensive understanding of the product's commercial readiness failed to launch. Urgency heightened as leadership sought a thorough and final evaluation of market readiness from a clinical, technical, and sales perspective under the structure of a clinical study. Although initially scoped for 10-12 months, the ask was to complete the study in an accelerated timeline of 3-4 months.

In response to this urgent priority, we swiftly assembled a program core team to craft a unique and innovative study requiring the incorporationof both quantitative technical data and qualitative human factors data. Mobilizing the team efficiently, I designed the "Living Lab" study, featuring a two-phased approach for evaluating both performance and Human Factors endpoints, utilizing healthy subjects as test patients and clinicians as end-user subjects. The entire study lifecycle, from development and start-up to initiation and enrollment, occurred at an accelerated pace, facilitated by collaborative efforts between the sponsor and sites and rigorous project management.

The Living Lab study, executed within an exceptionally tight timeline, delivered robust data and fairly conclusive findings in regards to market readiness. Armed with this critical information, the team formulated go-forward recommendations crucial for a significant business decision. This success not only showcased the team's agility and efficiency but also played a pivotal role in guiding the business toward informed strategies for the future. The VSPP Living Lab study stands as a testament to innovation and collaborative engagement, producing unique results within an expedited timeline.