Clinical Study Management and Operations
Study Level Planning and Development
- 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.
Site Level Planning and Development
- 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.
Study Execution
Study Execution
Study Execution
- 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.
Study Close-Out
Study Execution
Study Execution
- 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.