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Project Manager Medical

Location:
Chicago, Illinois, United States
Posted:
September 12, 2018

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Resume:

Ayesha Muzaffar M.D, MS

**** ******** ****** *

Hoffman Estates, IL 60169

Cell: 847-***-****

US Citizen ac601c@r.postjobfree.com

Professional Summary: Communication is key

Integral part of a leading academic institution, as an experienced research project manager, aiming to improve human health through scientific research. Results oriented 8 years of clinical trial management experience, with a proven history of exceeding recruitment goals nationally, increasing profitability, and departmental revenue.

With a Masters’ degree focused in research and regulatory compliance, overseeing all phases and aspects of drug and device clinical trial management from start up to close out. These include risk identification and resolution, quality and regulatory compliance, leadership and communication, research design and methodology, budget, billing and, project management.

Guide and assist a diverse group of investigators in translating novel techniques, and drugs into meaningful clinical trials, by collaborating across various departments of oncology, surgery, biomedical engineering, and radiology,? as well as internal and external vendors.

Work Experience 03/2016-Present Research Project Manager,

Northwestern University, Chicago

Site and affiliate operations

•Manage and oversee execution of national, departmental and affiliated sites’ drug and device clinical trials in compliance with protocol specifications, Good Clinical Practice guidelines, university policies, and federal regulations

•Serve as the department’s primary resource and liaison for projects with multiple sites in terms of site selection, feasibility assessments, and monitoring plans.

•Oversee completion of study activities per protocol including recruitment plans; ascertaining eligibility requirements, budget, payments, informed consent process, and study visit procedures.

•Review study progress and recommend revisions, amendments, or other study changes as necessary to meet the needs of sponsors/investigators.

•Establish study goals and desired outcomes; track deliverables to ensure timelines and milestones are attained

•Prepare and submit IRB and FDA documents such as consent forms, data security plans, study proposals, recruitment material and Investigational New Drug Applications (INDs) and IDEs.

•Oversee the maintenance of paper and electronic trial master file for each study

•Coordinate and facilitate review of study contracts and sub-contracts between the study sponsor, Northwestern and affiliates, ensuring the agreements are complete and, reviewed by all necessary officials

•Identify and escalate site and study issues to upper management as needed

•Prepare quarterly reports for upper management highlighting site and, study status including patients visits, study progress and recommend revisions, amendments, or other study changes as necessary

•Main point of contact for study sponsors, contract research organizations, Institutional Review Board, pharmacy, core labs, radiology and other vendors

•Identify and allocate study resources by collaborating with internal and external vendors to negotiate prices

•Work with procurement and sales team to bring Humanitarian use devices to Northwestern

•Knowledge of global studies and regulatory requirements for EU and Australia. Able to decipher and implement FDA guidance documents for drugs and devices

Budget and finance

•Develop and manage study budgets, decide and approve expenditures, review and approve invoices, process and track payments

•Ensure that the project meets associated revenue and expense goals

•Oversee all daily, monthly, and annual financial activities including transactions, analysis, and reporting

•Approve fund reallocation within budget as necessary and appropriate

Data management

•Manage database systems to meet research team needs. Design case report forms, monitor protocol accrual, abstract, and monitor entered data, assuring quality, and integrity

•Verify source documents, monitor and track research data entered by study staff at NU and external sites under NU subcontract.

•Provide investigators with interim and annual study reports

•Prepare safety reports and data safety monitoring plans for investigator-initiated studies to be submitted to the IRB and FDA

Education and Development

•Submit abstracts for conference presentation

•Present studies and results at conferences on behalf of the university

•Compile results for authorship of scientific papers and presentation

•Review scientific literature and recommend applicable techniques and procedures.

•Prepare results and co-author scientific papers for presentation and publication and disseminates information via seminars, lectures, etc.

•Use and teach project management tools such as Gantt chart and Work breakdown Structure to communicate study milestones and individual tasks within the team

•Educate new interns and assistants on the basic conduct of clinical trial

Leadership

•Staff and select project team; principal investigators, study teams, nurses, post docs, interns, sub-contractors, and vendors

•Supervise and train 10-15 staff members such as research coordinators, assistants, technicians, research nurses, volunteers, interns, students, residents, and post docs on various studies

•Meet regularly with staff about project progress and compliance

•Lead staff meeting, help set timelines and priorities and facilitate collaboration between faculty and staff

•Oversee hiring process; performance excellence plan for each employee; and merit increase process

•Ensure that an advising system, resources and courses are in place to support all interns, post-doctoral fellows, medical students on individual projects

08/2014 - 01/16 Clinical trials Project Lead

University of Chicago

•Created study documents such as consent forms, protocols and case report forms. Co-author scientific papers for presentation & publication & assist in writing of grants.

•Planned and executed all research related activities for onsite trials in the department of Neurology and Neuro Oncology

•Managed and trained a team of coordinators and nurses ensuring department SOP’s are followed, completion of the trial within the budget and protocol specific timelines and monitoring plan.

•Assisted in creation of budgets, grants and monitoring plans for PI initiated trials. Authored protocols, consent forms, and manuscripts. Designed documents necessary to conduct and monitor study visits including operational flow sheets, medication logs, patient information handouts, patient case report forms, and questionnaires.

•Developed and implemented recruitment and retention strategies, screened medical records to assess eligibility, reviewed paper and electronic data entry, and responded to complex sponsor queries

•Responsible for completing IRB material including initial IRB submission, amendments to the research and continuing reviews.

•Monitored investigator initiated trials for quality, safety, and data integrity. Assessed risks and developed monitoring plans accordingly.

03/2013-08/2014 Patient Intake Research

Alexian Brothers Medical Group, Chicago IL

•Identified, interviewed, and recruited potential patients for the clinic and clinical studies involving Oncology and Gastrointestinal studies.

•Transmitted correspondence with the IRB and medical records through electronic application system.

•Maintained and completed administrative and regulatory documents, case histories, consent forms, case report forms, and insurance.

•Maintained and completed the trial master file and subject binders. Ensured regulatory compliance throughout the research period.

•Performed various clerical and administrative functions, such as ordering and maintaining an inventory of supplies and investigational product.

•Performed all data entry, invoicing and billing. Documented and reported adverse events to the IRB and maintained research database until resolution.

02/2011-03/13 Clinical Research and Regulatory Project Coordinator (Contract) Apollo medical Research, Chicago, IL

•Performed and coordinated clinical trial activities from inception to completion mostly involving Diabetes and Hypertension studies.

•Conducted site management in accordance with ICH GCP, FDA guidelines, local regulations, and SOPs. Ensured accurate data collection, entry on CRFs and, query resolution in accordance with international quality assurance audits.

•Represented Apollo medical research in Investigator Meetings and trained site personnel.

•Trained clinic personnel to effectively complete study specific procedures and documentation. Identified and reported adverse events and unanticipated problems to the sponsor and followed until resolution.

•Interviewed, recruited, randomized, and followed patients throughout the studies, following protocol timelines and procedures. Maintained all subject files, logs, trial Master File, administrative and financial documents.

•Performed EKG, vital signs, phlebotomy, finger-stick blood collection and laboratory procedures.

06/2010-11/2010 Research Intern

Northwestern University, Chicago, IL

•Performed literature review on eliminating breast cancer disparities in metropolitan Chicago by using Pub med and end note.

•Attended meetings at Chicago department of Public Health on monthly basis.

•Exchanged ideas, making policies, interventions on how to eliminate racial and ethnic health disparities. Reviewed work done by different states and utilizing their ideas.

1/2006-9/2009 Resident Physician

Pakistan

Worked as a physician in the departments of Medicine, Surgery, and Nephrology, managing multiple simple and complex cases.

Education

Project Management Certification

2018 Northwestern University, IL

Masters of Regulatory Compliance and Clinical

2014-2016 Research (MSRC)

Northwestern University, Chicago IL

2014- 2015 Fundamentals of Clinical Research

Certification University of Chicago, IL

2000-2005 Bachelor of Science in Medicine and Surgery (M.B; B.S,

M.D) University of Karachi/Dow Medical College - Karachi

Hobbies & Interests

Painting (watercolor), baking, traveling, and spending time with family

Publications Peer Reviewed Journal Articles/Abstracts(Submitted)

Darwish M, Golnari P, Muzaffar A, Hurley MC, Potts MB, Shaibani A, Jahromi BS, Ansari SA. Standard CT/CTA Versus CT Perfusion RAPID Selection of Acute Ischemic Stroke Patients for Mechanical Thrombectomy in Early Presentations

Ansari S., Muzaffar A. High Resolution and Functional MRI assessment of Intracranial Atherosclerotic disease. Journal of the American College of Radiology. 2016, Jun; Pub Status: Pre Submission.

Bernard J., Reeder A., Javed A., Talmage G., Muzaffar A,. A Multicenter, Randomized, DoubleBlind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis.. Neurology. 2016, May; Pub Status: Submitted.

Xie T., Bernard, J., Muzaffar A.,. Effects of the Stimulation Frequency of the STN DBS on Swallowing Function and Freezing of Gait in Patients with Parkinson’s Disease: An Extended Chronic Phase Study.. Neurology. 2016, May; Pub Status: Submitted.

Poster Presentation

Author: Sameer Ansari MD, PhD, Presenter: Ayesha Muzaffar, MD. (August, 2016). High Resolution And Functional MRI Assessment of Intracranial Atherosclerotic Disease Poster presented at: Stroke Net Research Conference Northwestern University; Chicago, IL, USA.

Author: Shyam Prabhakaran, MD; Presenter: Ayesha Muzaffar, MD. (August, 2016). Mechanisms Of Early Recurrence In Intracranial Atherosclerotic Disease Poster presented at: Stroke Net Research Conference Northwestern University; Chicago, IL, USA.

Oral Presentation

Author: Gregory Albers, MD; Presenter: Ayesha Muzaffar. (June, 2016). Endovascular Therapy Following Image Evaluation For Ischemic Stroke (DEFUSE-3) Oral Presentation presented at: Stroke Net Research Conference Northwestern University; Chicago, IL, USA.

Author: Sponsor Guerbet, France; Presenter: Ayesha Muzaffar, MD. (August, 2016). P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Phase IIb Clinical Study Oral Presentation presented at: The Northwestern Neuro Disease Team, Northwestern University; Chicago, IL, USA.

Current Projects

1.DEFUSE 3: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

2.HEAT: Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

3.P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

4.LowEr Administered Dose with highEr Relaxivity: Gadovist vs. Dotarem- LEADER 75 19773

5.Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)

6.High Resolution and Functional MRI Assessment of Intracranial Atherosclerotic Plaque

7.RUPTURED ANEURYSMS TREATED WITH HYDROGEL COILS (RAGE)

8.Staging Intracranial Hemodynamic Failure with MRI

9.Evaluating safety of Penumbra coils in embolization of intracranial AVM’s and aneurysms

10.Role of 4D flow Magnetic Resonance Imaging in intracranial lesions

11.Illinois Stroke Intervention Registry and Trials Network (ISIRTN)

12.PulseRider® Aneurysm Neck Reconstruction Device (HUD)

13.Neuroform Microdelivery Stent System HUD

14.Wingspan Stent System with Gateway PTA Balloon Catheter

15.Codman Enterprise Vascular Reconstruction Device and Delivery System HUD

16.MicroVention Low-profile Visualized Intraluminal Support Device (LVIS®) and LVIS Jr. Humanitarian Use Device (HUD)

17.Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation prior to or following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)

18.MISTIE-III: A phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intra cerebral hemorrhage

Certifications And Systems

CITI and HIPAA

IRB training

Budget Development

ECFMG certification

TOEFL

IVRS, EMR (EPIC, powerchart)

RedCAP

Eclinical

cfusion

Oracle Inform

iDATAfax

WebDCU

Study tracker (eNOTIS)

NOTIS

Medidata



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