Profile Details

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Hire Sherry S.

United States

USD 65 /hr

Experienced Project Director Specializing in Ophthalmology (23 Years' experience)

Profile Summary

Sherry Sweeney Brandon, Florida +(1) 813-380-2684 Sherry.Sweeneyrn@gmail.com Summary of Experience Over 23 years of experience in clinical research including both pharmaceutical (Phase I-IV) and medical device trials. Served in various leadership positions including: Director, Clinical Operations Global Project Leader Senior Project Manager Clinical Trial Manager Global Senior Clinical Operations Leader Clinical Research Associate Site Research Manager Research Coordinator Critical Care Nurse Experienced leader in managing all aspects of the clinical trials process, including the following: Selecting / Managing CROs, vendors, and sites Lead many bid defenses with successful awards Leading cross function teams to ensure completion of timelines / milestones in accordance with contract Mentoring and line management Developing and adhering to a budget, timelines, and tracking metrics Developing and conducting in-depth program trainings and initiated process improvements Developing and reviewing all plans, documents, trainings, trackers, and tools Guaranteeing patient safety priority and regulatory compliance Maintaining data integrity Utilizing multiple CTMS, eTMF and eCRF systems Professional Experience Ora (Decentralized – Brandon, FL) Director Clinical Operations (Apr 2019 – present) Leader of bid defense prep and presentation for CRO Ophthalmic programs Primary clinical liaison for large pharma partnership / upper management liaison for client relations Leads team of Project Managers to win new business and ensure current projects are on budget in accordance to timelines Mentor Associate Project Managers and Project Managers Have ability to step in to manage any project for out of office times or other need Developed and lead process improvements companywide (including implementation of records management department) Ora (Decentralized – Brandon, FL) Senior Clinical Project Manager (Oct 2017 – April 2019) Leader of bid defense prep and presentation for Ophthalmic programs Planning and scheduling activities and deliverables for several Ophthalmic clinical trials from Phase I-III including cohort management and genetic therapy Managing budgetary issues, including financial tracking and control Serving as the primary liaison between clients, stakeholders, and team leaders Performed risk management assessments to minimize project risks Established and maintained relationships with vendors and third parties Created/ maintained comprehensive project documentation Interviewed/ hired/ trained/ mentored and managed department staff PAREXEL International (Decentralized - Brandon, FL) Global Project Leader (September 2015 – October 2017) Successfully managed global full-service trials Led global cross-functional teams in successful execution of patient recruitment and data collection in North America, Europe and Japan Ensured client expectations were being met according to contract and quality standards while maintaining internal efficiencies to keep operational costs at a minimum Managed budgetary issues, including financial tracking and control Served as the primary liaison between large partnership clients, stakeholders, and team leaders Routinely provided metrics to upper management to confirm financial goals were met and exceeded monthly throughout study progression. Performed risk management assessments to minimize project risks Established / maintained relationships with vendors and third parties Mentored Junior staff PAREXEL International (Decentralized - Brandon, FL) Senior Global Clinical Operations Leader (February 2008 – September 2015) Coordinated clinical activities for international, multi-center clinical trials Evaluated and selected research sites Initiated and monitored sites, and hosted termination activities Oversaw data collection Conducted quality control reviews to ensure compliance with protocols and regulations Coordinated communications between study start up teams, in-house monitoring teams, project managers, clinical investigators, and other site personnel Strong communication with large partnership clients Mentored and trained monitoring team; audited annual training files Conducted QC co-monitoring visits and reviewed trip reports Compiled monthly metrics reports Developed and managing project timelines Approved expense reports Developed study monitoring plans, project management plans, and communication plans Assisted with monitoring responses to internal and external audits Served as a functional expert at bid defense presentations Many presenting functions at internal and external meetings Mentored newly hired team members OccuLogix, Inc. (Decentralized - Brandon, FL) Clinical Trials Manager, (June 2004 – January 2008) Investigated, selected, and managed CROs Managed three multi-center clinical trials projects within the United States and Canada Developed and negotiated budgets, oversaw financial issues and expenses Managed and monitored research sites Oversaw quality control of data and GCPs Created and managed project timelines Developed study protocols and documents, including case report forms, consent forms, manuals, and study materials Conducted master file and site audits Hosted and main presenter at investigator meetings Coordinated data management, statistical analyses, and clinical summaries Managed vendor communications, contracts, and regulatory documentation Oversaw SOP and department process development efforts Bay Area Cardiology Associates (Tampa, FL) Research Manager (May 1997 – June 2004) Initiated and managed a clinical research department for the largest group of cardiologists in the Tampa Bay area Enrolling hundreds of patients in over forty pharmaceutical and medical device trials Developing departmental SOPs, including hiring and supervising department staff Proposing budgets and maintaining financial records Preparing and maintaining regulatory documents Coordinating all aspects of research studies Advising hospital and clinic staff on research protocols Screening participants and obtaining consent forms Conducting activities within cardiovascular, pharmaceutical, and medical device trials, including lab draws, drug dispensing, accountability, and patient follow-up University Community Hospital (Tampa, FL) Critical Care Nurse (August 1995 – April 1997) Administering medication to critical care patients, including advising about the purpose, correct dosage, possible adverse reactions Educating patients about medication administration prior to discharge Collaborating with physicians and other hospital personnel to coordinate patient care Assessing, evaluating, and documenting patient medical histories Identifying and implementing appropriate procedures for patient care Region 7 Hosp Corp (Miramichi, New Brunswick, Canada) Staff Nurse (1995) Same duties as described above Education Bathurst School of Nursing (Bathurst, New Brunswick, Canada) Area of Study: Nursing, Graduation Year: 1994 New Brunswick Community College (Moncton, New Brunswick, Canada) Area of Study: Entrepreneurship New Brunswick Community College (Moncton, New Brunswick, Canada) Area of Study: Business Technology Therapeutic Area Experience: Ophthalmology (Device and Pharmaceutical) - Ophthalmic Gene Therapy, Stem Cell Therapy, Diabetic Retinopathy, Diabetic macular edema, Age-related macular degeneration (wet and dry), Glaucoma, BRVO, CRVO, Retina Pigmentosa Cardiovascular Health (Device and Pharmaceutical) - Arrhythmia management, Acute myocardial infarction. Unstable angina pectoris, Hyperlipidemia, Cardiomyopathy, Congestive Heart Failure, stents trials, Anti-arrhythmic drugs, Thrombolytic agents, Anti-hypertensive drugs, Anti-platelet drugs and Anti-coagulant drugs Diabetes (Device and Pharmaceutical) - Type I diabetes. Type II diabetes Iron Deficiency Anemia Atopic Dermatitis

Subject Matter Expertise

• ★ Ophthalmology
• ☆ Clinical Trials
• ☆ Interventional Cardiology

Services

• Research

Research Feasibility Study

Work Experience

Project Director

Ora

October 2017 - Present

Education

Nursing

Bathurst School of Nursing

August 1991 - January 1994

Certifications

• Certification details not provided.