Summary
Overview
Work History
Education
Skills
Locations
Therapeuticexperience
Languages
References
Software
Work Availability
Timeline
SeniorSoftwareEngineer

Sandra Pagano, MPH

Burlington,KY

Summary

Results-driven individual with a solid track record in delivering quality work. Known for excellent communication and teamwork abilities, with a commitment to achieving company goals and delivering exceptional service. Passionate about continuous learning and professional development.

Overview

29
29
years of professional experience

Work History

Clinical Trial Manager II

Syneos Health
Raleigh, North Carolina
11.2020 - Current
  • Responsible for clinical management and monitoring all types of clinical trials; assures adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures.
  • Developed and implemented clinical trial management plans, protocols and reports.
  • Organized and managed clinical trials in compliance with ICH-GCP guidelines.
  • Reviewed study documents for accuracy, completeness and regulatory compliance.
  • Monitored progress of clinical trials, identified problems and developed solutions to ensure timely completion of studies.
  • Managed budgeting process including tracking actuals against budgeted costs for each trial.
  • Coordinated activities between internal staff members, vendors and third-party contractors involved in the execution of clinical trials.
  • Performed regular audits of sites participating in clinical trials to ensure adherence to GCP and ICH guidelines.
  • Created detailed timelines for each project to ensure milestones were met on schedule.
  • Participated in meetings with sponsors, CROs, investigators, regulatory agencies concerning ongoing projects.

Clinical Trial Manager

ICON PLC
Nashville, Tennessee
02.2019 - 10.2020
  • Acted as the Functional Lead from Clinical Research Services, with responsibility for delivery of all clinical aspects of clinical studies.
  • Developed and implemented clinical trial management plans, protocols and reports.
  • Organized and managed clinical trials in compliance with ICH-GCP guidelines.
  • Monitored progress of clinical trials, identified problems and developed solutions to ensure timely completion of studies.
  • Coordinated activities between internal staff members, vendors, and third-party contractors involved in the execution of clinical trials.
  • Performed regular audits of sites participating in clinical trials to ensure adherence to GCP and ICH guidelines.

Clinical Team Manager

PRA Health Sciences
Raleigh, North Carolina
06.2016 - 02.2019
  • Led the clinical team to ensure quality, including oversight of monitoring plans, audits findings, and deviation tracking/management.
  • Provided guidance, education and mentorship to new hires.
  • Ensured that organizational policies were adhered to by all clinical staff members.
  • Developed and implemented clinical protocols to ensure patient safety.
  • Monitored team productivity levels and took corrective action when necessary.
  • Maintained an effective communication system among the clinical team members.

Senior Clinical Trial Specialist

PRA Strategic Solutions
Raleigh, North Carolina
08.2014 - 06.2016
  • Acted as escalation point for site regarding routine study conduct, primary contact for urgent issues.
  • Coordinated with research personnel to ensure accurate data collection during trials.
  • Ensured compliance with Good Clinical Practice guidelines and all applicable regulations.
  • Performed ongoing monitoring of study progress and reported findings to management staff.
  • Maintained effective communication between sponsors, investigators, research coordinators, clinicians and other members of the team throughout the duration of the trial.
  • Created databases for tracking patient information gathered during clinical trials.
  • Prepared materials such as investigator brochures, medication labels, patient diaries., as needed.
  • Participated in audits conducted by external agencies such as FDA or IRB.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.

Clinical Trial Manager

CTI Clinical Trial Services, Inc.
Cincinnati, Ohio
03.2014 - 08.2014
  • Perform and coordinate project organization, implementation, and management activities.
  • Reviewed study documents for accuracy, completeness and regulatory compliance.
  • Monitored progress of clinical trials, identified problems and developed solutions to ensure timely completion of studies.
  • Coordinated activities between internal staff members, vendors and third party contractors involved in the execution of clinical trials.
  • Performed regular audits of sites participating in clinical trials to ensure adherence to GCP and ICH guidelines.
  • Presented updates about ongoing studies at internal team meetings and other relevant forums.
  • Participated in meetings with sponsors, CROs, investigators, regulatory agencies concerning ongoing projects.

Senior / Lead CRA

PPD
Wilmington, North Carolina
08.2011 - 03.2014
  • Coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs.
  • Developed study specific monitoring tools to ensure data accuracy and completeness.
  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Maintained accurate documentation of all on-site activities in the trial master file.
  • Tracked regulatory submissions to ethics committees and regulatory authorities.
  • Provided guidance to junior clinical research associates regarding protocol adherence, CRF completion and other aspects of the clinical trial process.
  • Monitored safety events reported by investigators or found during monitoring visits.
  • Participated in periodic conference calls with sponsor representatives.

Senior Clinical Research Associate (Contractor)

Quiintiles
Wilmington, North Carolina
04.2011 - 08.2011
  • Performed aspects of the clinical monitoring process in accordance with GCPs and global SOPs.
  • Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
  • Performed source document verification, data query resolution and reconciliation of discrepancies.
  • Reviewed protocols, case report forms and other study documents for accuracy.

Clinical Research Associate I / II

PPD
Wilmington, North Carolina
06.2007 - 04.2010
  • Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs.
  • Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
  • Conducted site initiation visits and monitored ongoing studies at investigator sites.
  • Assessed incoming source documentation for accuracy and completeness against case report forms.
  • Ensured proper storage of investigational product at investigator sites per GCP guidelines.
  • Monitored safety events reported during the course of clinical trials in accordance with SOPs.
  • Participated in internal audits related to clinical research operations processes.
  • Participated in educational training, activities, and professional development programs.

Project Manager

PPD Global Central Labs
Highland Heights, Kentucky
05.2003 - 06.2007
  • Managed pharmaceutical clinical trials (Phases I-IV, Global and US only) for the Global Central Lab.
  • Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
  • Presented lab processes and procedures to site personnel at Investigator Meetings.
  • Coordinated study setup, conduction, and closeout for a multidisciplinary central laboratory team to include programming specifications, lab kit specifications, shipment of initial supplies, and inventory tracking.
  • Coordinated movement of laboratory samples by establishing and enforcing security and safety standards.
  • Communicated with internal customers to deliver appropriate clinical supplies to key areas and meet ongoing operational demands.

Study Coordinator

Medpace
Cincinnati, Ohio
04.2002 - 05.2003
  • Created reports summarizing patient recruitment activities, enrollment numbers, and adverse events.
  • Coordinated research site visits for sponsors and monitors by arranging travel logistics, scheduling meetings, compiling documentation for review sessions.
  • Maintained close communication with project teams including investigators, CRAs, vendors and external partners regarding study milestones and timelines.
  • Participated in feasibility assessments at potential investigative sites in order to determine suitability for participation in a given study.
  • Responded promptly to inquiries from investigational sites pertaining to study-specific issues or questions.

Research Coordinator IV

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio
04.2000 - 04.2002
  • Primary Research Coordinator on NIH Grant from National Institute of Child Health and Human Development.
  • Conducted literature reviews to identify key studies relevant to research project objectives.
  • Organized and facilitated focus groups with study participants to collect qualitative data.
  • Coordinated the recruitment of study participants through various channels, such as targeted advertisements and referrals from community partners.
  • Reviewed consent forms for accuracy and completeness prior to participant enrollment in the study.
  • Prepared reports summarizing research findings for presentation at conferences and meetings with external stakeholders.
  • Participated in weekly team meetings to discuss progress on current projects and plan future initiatives.
  • Detailed results and conclusions in professionally-prepared documents, reports and presentations.

Research Assistant

University of Cincinnati
Cincinnati, Ohio
03.1998 - 03.2000
  • Primary Research Assistant on the NIH Women's Health Initiative Study.
  • Assisted in the design and implementation of experimental protocol.
  • Collaborated with site staff in developing a data collection tool.
  • Maintained a database of all research activities conducted during the course of the project.
  • Set up, calibrated, and maintained laboratory research equipment.
  • Developed exemplary rapport with personnel and patients by demonstrating compassion and research expertise.
  • Collected blood samples and prepared hematology and chemistry samples for shipment to central lab.
  • Supervised supplies in inventory and notified supervisor of low stock levels.

Public Health Officer

U.S. Air Force
Fayetteville, North Carolina
05.1997 - 03.1998
  • Managed Public Health and Immunization Offices, including immunization tracking, deployment briefings, and Public Health Counseling.
  • Developed and presented strategies to promote healthy lifestyles among the general population.
  • Provided training sessions for healthcare workers on topics such as infection control procedures or emergency preparedness protocols.
  • Maintained accurate records regarding all activities related to public health services rendered.
  • Monitored environmental factors that may impact public health outcomes, such as water contamination levels and food handling.

Site Coordinator

University of South Florida
Tampa, Florida
07.1995 - 05.1997
  • Managed two concurrent Phase III clinical trials for Alzheimer's Disease.
  • Coordinated patient appointments and maintained appointment schedule.
  • Assisted with the development of efficient office procedures for improved workflow.
  • Managed medical records by filing documents into appropriate folders according to established protocols.
  • Prepared patient charts prior to visits as well as updated records after each visit.
  • Ensured all paperwork related to patient care was completed accurately and entered into EDC in a timely manner.

Education

Masters - Public Health / Epidemiology

University of South Florida
United States
05.1995

Bachelor - Allied Health Sciences

Slippery Rock University
United States
05.1992

Skills

  • Training and mentoring
  • Stakeholder Communication
  • Teamwork and Collaboration
  • Conflict Resolution
  • Results-Oriented
  • Adaptability and Flexibility

Locations

  • Raleigh, Raleigh, North Carolina
  • Nashville, Nashville, Tennessee
  • Cincinnati, Cincinnati, Ohio
  • Wilmington, Wilmington, North Carolina
  • Highland Heights, Highland Heights, Kentucky
  • Fayetteville, Fayetteville, North Carolina
  • Tampa, Tampa, Florida

Therapeuticexperience

  • Dermatology
  • Psoriatic Arthritis
  • Rare Disease
  • Scleroderma
  • Anti-Infective Device
  • Heart Failure Device
  • Endocrinology/Metabolism
  • Gastroenterology
  • Celiac Disease
  • Colitis, Ulcerative
  • Crohn's disease
  • Hepatology
  • Non-Alcoholic Steatohepatitis
  • Infectious Diseases Immunization
  • Immunology / Inflammatory
  • Rheumatoid Arthritis
  • Neurology
  • Alzheimers Disease
  • Oncology
  • Cancer, Advanced Solid Malignancies
  • Cancer, B Cell Lymphoma
  • Cancer, Follicular Lymphoma
  • Cancer, Lung Non Small Cell
  • Cancer, Melanoma
  • Cancer, Prostate
  • Cancer, Squamous Cell
  • Psychiatry
  • Schizophrenia
  • Respiratory
  • Asthma

Languages

English, Native

References

References available upon request.

Software

Microsoft Office

Veeva Vault (eTMF)

Spotfire

Oracle

IMedidata / RAVE

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Clinical Trial Manager II

Syneos Health
11.2020 - Current

Clinical Trial Manager

ICON PLC
02.2019 - 10.2020

Clinical Team Manager

PRA Health Sciences
06.2016 - 02.2019

Senior Clinical Trial Specialist

PRA Strategic Solutions
08.2014 - 06.2016

Clinical Trial Manager

CTI Clinical Trial Services, Inc.
03.2014 - 08.2014

Senior / Lead CRA

PPD
08.2011 - 03.2014

Senior Clinical Research Associate (Contractor)

Quiintiles
04.2011 - 08.2011

Clinical Research Associate I / II

PPD
06.2007 - 04.2010

Project Manager

PPD Global Central Labs
05.2003 - 06.2007

Study Coordinator

Medpace
04.2002 - 05.2003

Research Coordinator IV

Cincinnati Children's Hospital Medical Center
04.2000 - 04.2002

Research Assistant

University of Cincinnati
03.1998 - 03.2000

Public Health Officer

U.S. Air Force
05.1997 - 03.1998

Site Coordinator

University of South Florida
07.1995 - 05.1997

Masters - Public Health / Epidemiology

University of South Florida

Bachelor - Allied Health Sciences

Slippery Rock University

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Sandra Pagano, MPH