MedQIA, WorldCare Clinical, and DARC have merged to form VOIANT• Contribute to the development of independent review charters, site manuals, review manuals, standard operation procedures (SOPs), electronic case report forms (eCRF), user requirement specifications (URS), and data transfer specifications (DTS) for clinical trials.• Interface strategically and operationally across functional areas including data management, clinical operations, statistics, and QA, providing training, teaching, and consistent troubleshooting.• Responsible for the training and testing of sites and reviewers (including, radiologists, technologists, neurologists, oncologists, rheumatologists, immunologists, pathologists).• Work independently to research and implement novel read criteria.• Represent Voiant, including speaking, at key meetings including conferences, investigator, and governance meetings.• Lead the development of scientific clinical trial documents.• Mentor junior team members. Responsible for training of internal team members.• Advise and assist Operations from a scientific standpoint with effective delivery.• Review study data and prepare reports to monitor reviewer performance, identify data issues and inconsistencies, and assist in identifying trends.• Work closely with KOLs to accumulate medical/scientific knowledge necessary to support study designs proposed to potential and existing clients.• Support science related business development activities including, scientific language for proposals, bid defenses, science/reader activities, creating and hosting webinars, authoring publications.

• Manage over 10 staff responsible for clinical project management of global imaging clinical trials.• Ensure project management staff are performing high-quality work on their studies. • Review timelines, resourcing, and opportunities for improvement with Program Management to address risks and/or issues to ensure deliverables are met. • Interact with internal cross-functional teams to support assigned clinical trials. • Manage efforts to ensure timely completion of contracted deliverables. • Monitor trial progress and budget. • Manage escalation of issues and communicate as appropriate. • Produce reports and presentations as required. • Provide status updates to appropriate parties. • Originate Standard Operating Procedures and Study Specific Protocols.

We provide input, guidance and support for imaging endpoint based clinical trials in oncology, neurology, and musculoskeletal (MSK).Modalities supported: MRI, CT, PET, SPECT, X-Ray, US. We also provide education, guidance and support for imaging based biomarker projects with a neuropsychiatric focus, from conception through implementation and disseminating of results. Imaging - Designing imaging studies. From what hypothesis do you want to test, through selecting participant population, psychometrics and imaging technique for hypothesis testing, to support for imaging and statistical data analysis.Recruitment - Participant selection criteria, and strategies to optimize participant enrollment.Psychometrics - Behavioral and cognitive/cognition metrics selection.Biomarkers - Non-imaging based biomarker selection.IRB - Writing IRB protocol, submitting, modifications, and continuing reviews.Data analysis - Power calculations through Data Science approaches.Disseminating of Results - Slides and posters, article and grant writing.Education - Creating educational material and teaching.Medical Writing - Writing Standard Operational Procedures, Manual of Operations, Informed Consent Forms, Assent Forms, requiring plain-language editing. Familiar with advanced medical terminology and the ability to understand and communicate complex information. Writing copy for advertising flyers in hard and electronic versions. Editing (stylistic and copy) others’ manuscripts and grants. Working with Microsoft and Adobe products. CITI, GCP trained. Familiar with FDA regulatory requirements and IND submissions. Hands on experience with data acquisition, pulse programming (Bruker, Agilent, Siemens, GE), image registration, and statistical analysis with a variety of processing packages (OSIRIX, ITK-SNAP, jip-align, FSL, SPM, LCModel, Gannet, FELIX). Facile with general programming tools/environments: UNIX/Linux, MATLAB, R, Python, SQL.