Sherri Clearlake Email & Phone Number

Remote based Senior CDM managing transfer and closeout of clinical trials•Resume responsibility for Data Management tasks for PICI trials transferred to LumaBridge•Responsible and accountable for managing all aspects of clinical data review and integrity.•Maintain EDC, update as required, and ensure a clean database lock (Veeva CDMS)•Use Tableau™ and other tools for data cleaning and analysis.•Update Data Management SOPs for PICI studies under LumaBridge oversight.•Apply process management skills to support developing best practices in a growing DM group.

Home Based

Remote based Senior CDM and acting manager.•Responsible and accountable for managing all aspects of clinical data, from protocol review to eCRF/EDC design to data cleaning and final data lock. (Medidata RaveX®, Veeva CDMS)•Use Tableau™ and other tools for data cleaning and analysis.•Develop and implement SOPs, standardize Data Management processes and policies.•Work closely with staff at member institutions as well as external stakeholders, vendors, and PICI staff to plan, staff, implement, and evaluate collaborative clinical trials.

Costa Rica

One month of intensive Spanish lessons. This is a great school!

Home Based

Remote-based leader responsible for all aspects of clinical data management and building processes to support both sponsor and companion diagnostic studies.•Define data management related business and research protocol requirements. Provide ongoing support and subject matter expertise for data management related activities.•Initiate, plan, execute and manage all aspects of data management from case report form development to the final database lock. CRF/EDC design, database/edit check specification requirements, user acceptance testing, and user training. •Use Tableau™ and other tools to turn data into stories for research and sales staff. •Develop SOPs supporting the development of a robust Good Clinical Practices program.•Member of cross-functional team building a regulatory framework for the developing liquid biopsy companion diagnostic space.Medrio® EDC, CRAB Nebula™ EDC, ABBYY® Fine Reader

Menlo Park, Ca

Responsible for management of clinical data and assuring quality of data delivery. •Define data management related business requirements and support project teams. Provide subject matter expertise for data management related activities.•Initiate, plan, execute and manage all aspects of data management from case report form development to the final database lock. Case report form design, database/edit check specification requirements definition, user acceptance testing, creation and maintenance of the data management plan and the data quality plan. •Ensure the successful execution of data management elements of the project plan. This includes monitoring tasks and managing timelines related to data management deliverables, database development and database lock/freeze/snapshot.•Provide communication of risk & mitigation actions for all data management related deliverables•Define data review requirements and processes to ensure delivery of the highest quality of data.Clindex® EDCFebruary 2016 RIF.

San Francisco Bay Area

• Provide ongoing training, support, and timely trouble-ticket closure for Staff and Volunteer users of Shiftboard™.• Ensure the successful implementation of team systems software including the adoption of Shiftboard™ for volunteer shift scheduling for the Burning Man Event and year-round programs.• Work with ~30 event teams to implement new processes and tools for volunteer on-boarding, team communications, shift scheduling, event preparation, participation tracking, and data integration across systems. • Respond to help-desk tickets for a global base of volunteers.• Project Manager for the design and adoption of Salesforce for Art Grants and event Art Support Teams.• Develop and deliver software and process training.• Use special powers of enthusiasm, communication, and persistence to ensure paid and volunteer staff meet commitments on time.

Santa Clara, Ca

•Managed people and processes responsible for the execution of clinical data management, clinical document control, investigational device management, and research related payments and billing.•Fostered a diverse and entrepreneurial workplace that enabled my staff of 17 employees to contribute to their full potential in pursuit of organizational objectives.•Recognized for coaching employees from poor to exceptional performance.•Built strategic partnerships to support departmental and organizational process standardization goals.•Subject Matter Expert on project teams designing eCRFs and EDC, CTMS integrations, divisional and external reporting, and building a robust regulatory compliance network across clinical and post-market divisions. Medidata Rave® EDC, Siebel® CTMS, Kofax Capture®, SAP®

Santa Clara, Ca

•Safety review of study protocols, annual reports, Safety sections of the Clinical Reports, Monitoring Plans, and other ad hoc reports which included safety data.•Data Manager with oversight of safety-related eCRF creation, UAT development and execution, developments of reports and dashboards , data cleaning and data table review.•Created CEC eCRFs, trained CEC to EDC, managed CRO/CEC relationship. •Identified and completed all adjudications of cohort patients prior to database lock including query resolution with physicians and CEC.Cognos®, MS Access®, InForm® EDC

• Applied medical and IT experience to eCRF design, and data table creation to support gathering of medically accurate and statistically relevant data.• Led group to meeting data cleaning goals supporting PMA submission completing five years of clinical research involving 800 patients and post-approval data for over 3000 patients. Obtained FDA approval of the first carotid stent in the US.• Integrated data collected from FDA mandated post-market trial to meet both clinical and complaint department needs and reporting (MDR & vigilance) regulations.eRT® EDC, SAS®

• Managed staff to meet required response time to product incident reports (MDR and vigilance), proper complaint handling and adhererence to regulations. Interactions included FDA and foreign regulatory bodies. • Applied medical background to development of position papers for reporting product and patient issues for emerging technologies, and for physician training. • Cross-divisional team member promoting standardizaion and coordination of company-wide compliance activites, policies, training, and reporting.

• Reviewed reported product issues per regulatory timelines to determine event reportability. • Provided FDA with compliance data during audit and product recall activities.

• Reviewed vascular structures on radiologic images to determine appropriateness of endovascular endograft for candidate patients.• Created training manuals and provided training to staff and physicians.

• Performed CT scans, mammograms and general x-ray examinations.• Applications manager for IDXRad radiology database.• Weekend staff supervisor.

Cambridge, Massachusetts, United States

Associate Of Science - As, Radiologic Technology/Science - Radiographer

Courses, Management

Courses, Instructional Design For Educators And Corporate Trainers

Certificate, Project And Program Management

Certificate, Clinical Trials Design And Management