Clinical Research Manager

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Clinical Study/Project Manager

Results-oriented clinical research professional with strong scientific acumen and expertise—poised for Research Operations roles. knowledge of FDA regulatory requirements and ICH/GCP guidelines. Highly adept at creating and reporting metrics on project management, tracking records, and performance. Developed and executed strategic projects that have improved operational workflows and processes in complex working environments. Recognized for initiative, organization, problem solving skills, time and task management, detail oriented, and focus on accuracy.

Key Strengths:

■ Project Management

■ Risk Assessment

■ Compliance Standards

■ Matrix Environment

■ Contingency Planning

■ ICH/GCP and Regulatory

■ Budget Management

■ Feasibility analysis

■ Resource Management

Managed Oncology clinical trials to Fortune 100 Pharma sponsors

Coordinated and managed Phase I, II, and III Oncology trials

Proven track record of facilitating and building relationships throughout the medical and scientific communities

• Cambridge International Diploma for Teachers and Trainers with Distinction. Cambridge University, 2012

• Cambridge International Certificate for Teachers and Trainers with Distinction. Cambridge University, 2011

• Bachelor of Dental Surgery (BDS)

Honorable Distinction, Cairo University, 2002

Virginia Cancer Specialists, US Oncology Network

Oncology Clinical Research Manager January 2020- present Oncology Clinical Research Supervisor May 2018 – January 2020 Member of US Oncology Research Operations Council

Member of VCS Protocol Feasibility Committee

Member of US Oncology Data Community of Practice

Member of US Oncology Technology Community of Practice

• Manage clinical research program and operations of 5 satellite sites with more than 200 phase I-II-III trials in accordance with US Oncology Research SOP and ICH GCP guidelines. Marwa Emam, BDS

Washington, DC adhfns@r.postjobfree.com 202-***-**** www.linkedin.com/in/marwaemam Oncology Clinical Trials Experience (Phase I/II/III): Cervical Cancer • Lymphoma • Leukemia • Head & Neck Squamous Cell Carcinoma • Non-Small Cell Lung Cancer Tumors • Solid Tumors • Melanoma • Breast • Gastrointestinal • Hematology EDUCATION & CREDENTIALS

RELEVANT EXPERIENCE

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• Perform trial management activities including study start up, enrollment, maintenance, close out, vendor oversight, regulatory obligations, data listing review, adverse event reporting and budget management.

• Collaborate with the Site Research Leader, physicians of the practice, the Research Committee, and other research management in the process of study selection for the research program.

• Accountable for the operational planning, feasibility, and execution of a clinical protocol.

• Act as a primary liaison between site and CRO and Sponsors to ensure timely study launch, conduct, and closeout according to contractual agreement.

• Lead study team to ensure quality, timelines, budget management and study deliverables across all applicable internal functional departments and vendors.

• Oversee all operational, financial and quality aspects of clinical studies. Responsible for ongoing monitoring of study activities.

• Develop contingency planning and risk mitigation strategies to ensure meeting or exceeding studies milestones.

• Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to senior management.

• Assist with resource management and team member transition by collaborating with appropriate managers and ensuring detailed Transition Plans are developed and implemented efficiently.

• Responsible for study management components of inspection readiness for all aspects of the study conduct.

• Evaluate quality trends and issues and develop training, policies and other corrective actions as necessary to drive positive change within site.

Sidney Kimmel Cancer Center, Sibley Memorial Hospital, Johns Hopkins University Oncology Research Program Coordinator, Oct 2016 – Apr 2018 Member of Sibley Hospital Cancer Committee, May 2017- Apr 2018

• Prepare trial application for IRB submission.

• Plan start-up and activation of new studies including PSVs, SIVs, design of data collection forms, drafting manuals of operations, informed consent statements, manage procurement and distribution of study drug and supplies and Vendor management.

• Prepare for termination and close out visits of clinical trials.

• Maintain ISF for each assigned protocol.

• Ensure HIPAA compliance as well as all federal, local, agency, and sponsor regulatory policies regarding the use of human subjects in research.

• Assist with the orientation and training of new research staff.

• Use principles of project management to coordinate fieldwork initiatives and deliverables.

• Act as main study contact and attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.

• Handle administrative pieces of research and clinical research management system (CTMS).

• Prepare for monitoring visits and audits of studies.

• Provide update on protocol implementation status and make recommendations on operational issues.

• Consent subjects verify their eligibility and enroll them on clinical trials.

• Perform data entry and validation to ensure accuracy, quality and compliance of data collection process.

• Report subject’s adverse and serious adverse events to the designated trial personnel.

• Document deviations, identify their root cause, and implement solutions.

• Prepare reports on individual patients or the study as required by the principal investigators and/or external agencies.

Various Teaching and Social Services positions

2014-2016

Nile Egyptian Schools, Cairo, Egypt

Head of Science Department and Instructional Coach, 2012-2013 Science Teacher, 2010-2013

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Dr. Foraida Dental Clinic, Cairo, Egypt

Manager- Dentist, 2006-2010

The Egyptian Ministry of Health, Fayoum, Egypt

Dentist, 2005-2006

Smile Dental Clinic, Egypt

Manager-Dentist, 2004-2005

Cairo University Hospital and Educational Hospitals of Ministry of Health, Egypt Dentist- Resident, 2002-2003

• Project Management Professional (PMP) Certificate, in progress

• Employment Law- McKesson, Apr 2020

• Setting Up Compliant Financial Operations and Budgets – Barnett International, Jan 2019

• Front Line Leader Program- McKesson, Sep 2018

• Fundamentals of Research Coordination – Johns Hopkins University, May 2017

• eIRB 10; prepare and submit an application – Johns Hopkins University, Apr 2017

• LEAN for Healthcare- Johns Hopkins University, Jan 2017

• Research Compliance- Johns Hopkins University, Nov 2016

• Basic Human Subjects Research (CITI), Oct 2016

• Clinical Research Billing Orientation, Oct 2016

• Clinical Research Management System (CRMS)- Johns Hopkins University, Oct 2016

• Conflict of Interest and Commitment- Johns Hopkins University, Oct 2016

• Good Clinical Practice (CITI), Oct 2016

• HIPAA for Research, Oct 2016

• Research Ethics- Johns Hopkins University, Oct 2016

• Cambridge International Examinations courses for curriculum implementation, student evaluation, formative and summative assessment, 2010-2013

Association of Clinical Research Professionals (ACRP), 2016–Present References available upon request.

CERTIFICATES

PROFESSIONAL AFFILIATIONS

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