Heather Friedman Email and Phone Number

Oversee the development, analyses, interpretation, and presentation of primary and secondary data in support of operational strategy and planning for both proposals and bid defenses, including working with the team to identify potential risks, and propose effective solutions as appropriate Conduct and oversee the data mining of internal and external databases and initiates/oversees the collection of primary data for use in development of robust strategies for high-profile, large, complex clinical trials across all therapeutic areas, including oncology and rare and pediatric diseases Provide project oversight to junior GFLs to ensure accuracy and quality of data, including review and QC of departmental deliverables at all stages of the feasibility Oversee departmental process improvement initiatives, implementation of feasibility related systems and tools, participate and lead intra- and interdepartmental meetings and initiativesManage and mentor direct reports and junior global feasibility team members

Oversee the development, analyses, interpretation, and presentation of primary and secondary data in support of operational strategy and planning for both proposals and bid defenses, including working with the team to identify potential risks, and propose effective solutions as appropriate Conduct and oversee the data mining of internal and external databases and initiates/oversees the collection of primary data for use in development of robust strategies for high-profile, large, complex clinical trials across all therapeutic areas, including oncology and rare and pediatric diseases Provide project oversight to junior GFLs to ensure accuracy and quality of data, including review and QC of departmental deliverables at all stages of the feasibility Oversee departmental process improvement initiatives, implementation of feasibility related systems and tools, participate and lead intra- and interdepartmental meetings and initiativesManage and mentor direct reports and junior global feasibility team members

Conducts data mining including development of the data strategy, analysis and interpretation of internal and external databases and initiates/oversees the collection of primary data for use in development of robust strategies for high-profile, large, complex clinical trials (country/site mix, site selection, enrollment modeling). Development of proposals and bid defenses; provides recommendations on the most appropriate use of data to support proposals and bid defense presentations, works with the team to identify potential risks, and is able to propose effective solutions as appropriateIndependently lead cross functional teams in standalone feasibility efforts; responsible for final report creation and delivery, including discussion of findings and recommendations with external clientsParticipates in intra and inter-departmental meetings, leading/contributing to the presentation of information on feasibility offerings, demonstrating continued value-add of the department and providing training on best practices, processes and tools.

Full oversight and ownership of the Feasibility/Site identification process: survey development and programming, local resource training and oversight, oversight of site outreach process, creation of progress reports, site selection tool and decision making, client and customer facing.Responsible for setup and conduct for feasibility/site identification studies according to timeline and quality standards and client expectations.Develop the initial site list for feasibility and site identification utilizing extensive internal and external datasets, preaward data, and client preference

Manage the research core, including imaging and coordinator support for over 75 clinical trials, protocol development, coverage analysis, budget development, contracts routing, data management and analysis, federal and sponsor-specific grant development, and resource allocationDevelop and implement departmental SOPs to establish the CIRC as a data coordinating center for multi-site trialsDevelop and implement QA/QI procedures and policiesDevelop and implement internal invoicing processesMaintain and report departmental records of annual volumes and financial metricsMaintain study budgetsDevelop program for departmental QA audits Serve as site PI for a foundation funded multi-site studyEnsure research billing and regulatory compliance and budget adherence Ensure bioethical and regulatory compliance for all studies utilizing the coreDevelop marketing materials to increase inter-departmental collaborationsTrain Research Coordinator to carry out study timelines and protocolsTrain Cardiology fellows and attendings on basic clinical research protocol development, bioethics, and compliance issuesMaintain study databases

Manage all aspects of numerous prospective and retrospective NIH funded and investigator-initiated clinical trials, including organizing many different trial timelines, subject recruitment, developing, maintaining and submitting all IRB and other regulatory materials, data analysis, and manuscript preparation.Assist in daily management of all trials within the health system that utilize the imaging coreDevelopment of study budgetsAdminister all testing protocolsFacilitate relationships with other area hospitals for recruitment purposesMaintain study databasesConduct all patient visits

Manage all aspects of numerous sponsored and NIH funded clinical trials, including organizing many different trial timelines, subject recruitment, developing, maintaining and submitting all IRB, central IRB and other regulatory materials, and coordinate relationships with the primary CRO and other supplementary research organizations. Develop a tissue banking study protocolAdminister all testing protocolsFacilitate relationships with other area hospitals and community health centers for recruitment purposesMaintain study databasesConduct all primary biologic sample lab workConduct all patient visits

Developed a quantitative/qualitative survey to assess water sanitation needs in the Kimana Group RanchAided in data analysis and interpretation using CSPro and EpiInfo softwarePresented results and recommendations to over 100 community stakeholders, government officials, and tribal leaders

Served as EMT for private ambulance company and aided in interpretation and translation between partner EMT's, as well as between EMT's and patients.

Developed exercise physiology/endocrinology research study Conducted the study, administered testing protocol, data analysis and interpretationWrote/submitted a final journal article for publication