SYDNEY R. BANTOM
Secane,USA
Summary
Seasoned Clinical Research professional with a background in Phase I through IV regional and global clinical trial management in a variety of therapeutic areas and various clinical research roles. Skills in trial, vendor, risk and site management.
Overview
24
24
years of professional experience
Work History
Risk Based Study Management Lead (Clinical Pharmacology)
ICON
North Wales, USA
06.2023 - Current
- Lead the risk-based study management activities across multiple Pain and Cystic Fibrosis Phase I studies throughout the study lifecycle, including the Risk-based SDV strategy
- Escalate risk trends across studies to senior management
- Key member of the cross-functional study team to oversee the risk review process for potential risks that may become issues regarding subject safety and/or data integrity
- Document risks in the OPRA-RAM risk management system from initial risk finding to its resolution
Clinical Trial Manager (Neuroscience)
Advanced Clinical
Deerfield, USA
10.2022 - 06.2023
- Co-lead the Clinical Operations study start-up activities for an outsourced, global, Phase II, Parkinson’s Disease study
- Co-lead oversight of study vendors and internal, cross-functional team
- Lead the planning of US and EU Investigator Meetings
- Facilitated process change for contract and budget execution
Clinical Trial Manager (Immunology)
ICON
North Wales, USA
05.2021 - 08.2022
- Co-lead the Clinical Operations study start-up activities for an outsourced, global, Phase III, Crohn’s Disease study
- Participated in study and vendor kick-off activities
- Facilitated the development of key study documents
- Collaborated with CRO for site feasibility and selection activities
Clinical Research Manager (Medical Device)
INTEGRA LIFESCIENCES
Princeton, USA
09.2019 - 05.2021
- Lead the day-to-day activities for US-only, Post-Market Clinical Follow Up (PMCF) orthopedic, nerve repair and extraventricular drain studies
- Clinical Lead for the development of a nerve product registry
- Authored protocols with Medical Affairs and initiate study start-up activities, including ICF, study plans and CRF development, feasibility/site selection and set-up of study systems
- Developed study timelines
- Financial oversight of studies, including input into the overall study and site budgets and approving investigator payments
- Cross-functional oversight of internal team and oversight of CRO
- Vendor management, including review and approval of proposals
- Authored SOPs for Operations department
- Clinical Operations representative to perform a vendor audit for approval of a new CRO for outsourced studies
- Attended an orthopedic fellows conference for therapeutic area training, including cadaver lab product training
Clinical Study Manager (Immunology)
CSL BEHRING
King of Prussia, USA
08.2018 - 08.2019
- Participated in the management of CRO and cross-functional teams for study start-up activities for global, Phase II (Immunology Program – Hizentra and Privigen) scleroderma studies
- Drafted and finalized key study documents for study conduct and regulatory submissions
- Drove feasibility activities with the Operations team for site selection
- Participated in the selection of program-level vendors, including review of RFPs and bid defense attendance, for current and future studies
- Lead/co-lead oversight of study vendors
- Participated in study timeline development and tracking for overall study and functional group milestones
- Collaborated with Finance, Legal and Site Management for the review and the full execution of site and vendor contracts
Senior Clinical Lead (Oncology)
IQVIA (formerly QuintilesIMS)
Raleigh-Durham, USA
04.2016 - 08.2018
- Lead the day-to-day activities for North America and APAC on global, Phase I (Tencentriq Program) and Phase III Oncology studies
- Managed clinical, operational and quality aspects of assigned study per ICH GCP guidelines
- Proactively identified, managed and escalated study and site issues through to resolution
- Managed a team of CRAs, CTAs and other support staff, including resourcing, site assignments, visit schedules
- Facilitated global investigator payments and monthly payments for the overall Clinical budget
- Collaborated with Project Management for vendor management and study deliverables
- Lead global CRA teleconferences
- Drafted and finalized study newsletters
- Presented clinical segment at a bid defense meeting
Clinical Team Manager (Oncology)
PPD
Wilmington, USA
08.2015 - 04.2016
- Lead the day-to-day activities for North America on a global, Phase III Oncology study
- Managed a team of CRAs, including resourcing, site assignments, visit schedules, and review and approval of monitoring reports
- On-boarded new CRAs, request sponsor training, vendor systems access and ensure timely completion of all required trainings
- Managed sponsor audits of sites, including findings resolution
- Tracked and managed study using study metrics to meet study timelines
- Participated in the management of the study budget for North America, including forecasting and posting of actual units in payment system
- Attended United States Investigator Meeting
- Co-lead weekly CRA teleconferences with the Global Clinical Team Manager
- Facilitated the collection and review of regulatory documents for IRB submissions, approvals and drug shipments
Clinical Project Manager (Dermatology)
GLOBAL EMPLOYMENT SOLUTIONS
Wayne, USA
03.2015 - 05.2015
- Lead the day-to-day Site Management activities for a Phase I Dermatology study
- Managed Field Operations team, including the creation of CRA and monitor visit trainings and review and approval of monitoring reports
- Developed study timelines
- Reviewed and approved site contracts and budgets
- Developed Project, Safety and Monitoring Plans
- Assisted in the finalization of eCRFs and Data Entry Guidelines
- Provided weekly study metrics
- Oversaw study vendors
- Reviewed and approved study-specific and protocol-related documents
- Facilitated the collection and review of regulatory documents for IRB submissions, approvals and drug shipments
- Developed working knowledge of electronic document management system and ensure ongoing collection and filing of essential documents into eTMF for Sponsor and internal QA/QC review
- Developed in-depth knowledge of Therapeutic Area
Clinical Data Liaison (Oncology)
GLAXOSMITHKLINE
Upper Providence, USA
07.2013 - 03.2015
- Managed data management, in-stream collection activities along with Study, Project Management, and Operations for global, Phase II and III Oncology studies
- Provided data metrics and trends in preparation for quarterly IDMC meetings to ensure quality data delivery
- Developed strategies with the study team for site, program, eCRF compliance issues
Clinical Scientist (Oncology)
MERCK & CO., INC.
North Wales, USA
03.2012 - 06.2013
- Lead the development and finalization of program-level Risk Language for multiple global, Phase I Oncology studies (Keytruda Program)
- Lead imaging collection activities and support sample procurement activities, including lab manual updates per protocol amendments, with vendor/CRO, sites, Project Management and Operations group
- Facilitated the development of an annual Confidential Investigators Brochure update and an abbreviated Clinical Study Report
- Participated in Medical Monitoring activities, including tracking of Adverse Event/Serious Adverse Event/Events of Clinical Interest trends
Sr. Clinical Trial Specialist (Oncology)
AMGEN, INC.
Thousand Oaks, USA
11.2008 - 02.2012
- Responsible for the day-to-day activities for Phase II and III global clinical studies in adherence to all applicable Standard Operating Procedures and Good Clinical Practices
- Participated in the management of cross-functional teams
- Vendor/CRO management lead/co-lead for activities such as User Acceptance Testing, EDC database creation and maintenance, review and approval of the Statement of Work, IVRS, lab collection and storage, recruitment and retention, and study equipment provisioning
- Provided weekly project management study metrics
- Lead weekly study team and vendor meetings
- Prepared and conducted study start-up and protocol amendment Site Evaluation Visit and Site Initiation Visit presentation trainings for the field operations team
- Served as primary point of contact for global and regional study sites
- Lead and participated in study planning and the management of study start-up, maintenance and close-out activities for Europe, North America, Latin and South America, Asia and Australia
- Facilitated data collection and medical monitoring for safety reviews
- Lead and managed field operations team and oversee site management activities
- Participated in the protocol and Informed Consent Form review and approval process for the initial protocol and subsequent amendments
- Facilitated the development of Case Report Forms and Study Plans
- Collaborated with Clinical Lead to submit protocol amendment updates to ClinTrials.gov
- Drafted and finalized monthly study newsletter and correspondence to sites
Clinical Research Specialist (Oncology, Respiratory, Urology)
MERCK & CO., INC.
North Wales, USA
10.2006 - 10.2008
- Managed the start-up activities for a global Phase III protocol (Emend Program)
- Clinical Lead responsible for timeline and study budget management, recruitment and tracking of enrollment, drug re-supply and accountability, data review, regulatory submissions and approvals, and shepherding an abstract and manuscript through to publication for a colorectal cancer, Merck Investigator Initiated Study (IIS)
- Lead Interim CRS for a study responsible for shepherding a protocol amendment through to finalization, assisting with an interim database lock for an interim analysis and providing feedback for site correspondence
- Assisted with the program-level Risk Management Plan and participated in Risk Management meetings
- Performed literature searches, assembly of the appendices and attachments, writing and proofreading the core and details sections of oncology supportive care, respiratory and urology protocols
- Assisted with data collection efforts and medical monitoring for interim and final analyses and Clinical Study Report preparation, including review of all tables and listings
- Performed quarterly review and reconciliation of patient safety narratives and reported safety events in EDC
- Completed the annual updates for the GI Confidential Investigators Brochure and NDA and IND annual updates
- Assisted with development of IDMC Charter for a Phase III study
- Assisted with the clinical close-out activities of two studies, including review and approval of monitoring reports and collection of all essential documents in MIDAS Trial Master File
Clinical Program Associate II, (Medical Device, Oral Contraceptives)
DURAMED RESEARCH, INC.
Bala Cynwyd, USA
12.2005 - 10.2006
- Responsible for all phases of two Phase II Women’s Health studies, including site selection, study start-up and maintenance
- Prepared sites for initiation visits for the regional monitors by sending the regulatory binder, study drug, lab kits and CRFs to sites
- Managed all study maintenance activities such as resolve site and vendor issues, maintain current investigative and general study files, complete all site re-supply requests for study drug, CRFs and lab kits, track subject enrollment, and assist monitors with the resolution of site issues
- Gained extensive knowledge of TMF and document requirements as the TMF Owner of the master study and investigator files to maintain audit readiness
- Maintained working relationship with Regulatory for essential document approval
- Collaborated with the QA/QC group for internal investigator file audit
- Reviewed and approved site and vendor invoices and attended monthly finance meetings to balance study budget
- Participated and involved in site audits
- Assisted the In-house CRA with duties such as co-monitoring on pre-study, initiation and interim visits, assign study sites to regional monitors, write Study-Specific Plans, revise the ICF to reflect the updates to a new amendment; write a quarterly, study newsletter, and facilitate weekly study meetings and monthly monitor teleconferences
- Served as primary contact for all study-related questions from sites
In-house CRA (Osteoporosis)
COVANCE, INC.
Radnor, USA
07.2005 - 12.2005
- Liaison between the Sponsor Company, data management vendor and study sites for three Phase IIIb Osteoporosis clinical trials (Boniva)
- Performed study maintenance activities such as enrollment tracking
- Served as a TMF Co-Owner of the study and investigator files to maintain audit readiness and prepare for study close-out
- Conducted monthly calls to generate remote monitoring reports for 30-45 sites to verify study accrual and drug supply, obtain patient status for any participants who had Serious Adverse Events or protocol violations, rectify Data Clarification Forms and notify the study staff of any new changes to the study
- Ensured timely reporting and appropriate filing of Safety reports to sites
- Served as primary contact for all study-related questions from sites
Clinical Research Associate (Oncology)
FOX CHASE CANCER CENTER
Philadelphia, USA
03.2005 - 07.2005
- Performed data management and Study Coordinator activities for four Phase I-III lung cancer studies, including preparation for a database lock and study close-out
- Managed sponsor personnel (site monitors)
- Managed PI for signature sign-off for database lock, protocol signature pages and meetings between the PI and sponsor personnel
- Responsible for drug supply, accountability and destruction
Data Manager/Lead Study Coordinator (Oncology)
UNIVERSITY OF PENNSYLVANIA CANCER CENTER
Philadelphia, USA
06.2001 - 03.2005
- Data Management Lead for four breast cancer and Hematology/Oncology studies, including medical record and pathology report abstraction
- Screened, consented and enrolled subjects, including the collection of biological samples
- Assisted with patient recruitment and recruitment strategies, including the advertisement of a research study on a reputable breast cancer website and attendance at local health fairs and seminars
- Trained new study team members and work-study students
- Assisted with writing the Standard Operating Procedures for the research/clinical group
Education
B.A. - Psychology
Temple University
Skills
- Clinical trial management
- Risk-based study management
- Data management
- Site management
- Clinical data review
- Protocol development
- Multidisciplinary team collaboration
Systemsexperience
- Microsoft Office
- InForm
- Medidata Rave
- JReview
- Spotfire
- Veeva Vault (CTMS, EDC)
Publications
Mark S. Chapell, William Beltran, Mark Santanello, Masami Takahashi, Sydney R. Bantom, John S. Donovan, Sara C. Hernandez, Thea M. Oculato, Nicole M. Ray, MEN AND WOMEN HOLDING HANDS: II. WHOSE HAND IS UPPERMOST?, Perceptual and Motor Skills, 89, 537-549, 1999
Therapeuticareaexperience
- Clinical Pharmacology – Pain, Cystic Fibrosis
- Neuroscience – Parkinson’s Disease
- Immunology – Scleroderma, Irritable Bowel Syndrome
- Oncology – Breast, Ovarian, Leukemia, MDS, Lymphoma, Lung, Supportive Care, Liver, Metastatic GI, Kidney, Melanoma
- Medical Device – Endometriosis, Orthopedics, Nerve Repair, Extraventricular Drain
- Women’s Health – Osteoporosis, Oral Contraceptives
- Respiratory – Asthma
- Urology – Overactive Bladder
- Dermatology – Acne
Professional Development
- Diversity in Clinical Trials, The Accreditation Council for Medical Affairs (ACMA), 04/01/23
- Coding with MedDRA, 10/01/19
- On-Demand PMP Bootcamp, PMtraining – R.E.P. #3962 Project Management Institute, 08/01/15, 35 PMI contact hours, plus 35 PDUs
- Preparing for a Clinical Trial Budget, DIA, 06/01/14, 0.2 CEUs
- Essentials of Project Management (full series), Project Management Institute, 05/01/14, 23 PDUs
- Microsoft Project 2013, Simplilearn, 05/01/14, 30 PDUs
- Risk-Based Monitoring: The Essentials for CRAs, Association of Clinical Research Professionals, 04/01/14, 1 contact hour
- Approaches to Address Challenges in Vendor Management, Barnett Educational Services, 12/01/10, 2.5 contact hours
- Introduction to Clinical Research, Villanova University College of Nursing, 04/01/06, 32 contact hours
Timeline
Risk Based Study Management Lead (Clinical Pharmacology)
ICON
06.2023 - Current
Clinical Trial Manager (Neuroscience)
Advanced Clinical
10.2022 - 06.2023
Clinical Trial Manager (Immunology)
ICON
05.2021 - 08.2022
Clinical Research Manager (Medical Device)
INTEGRA LIFESCIENCES
09.2019 - 05.2021
Clinical Study Manager (Immunology)
CSL BEHRING
08.2018 - 08.2019
Senior Clinical Lead (Oncology)
IQVIA (formerly QuintilesIMS)
04.2016 - 08.2018
Clinical Team Manager (Oncology)
PPD
08.2015 - 04.2016
Clinical Project Manager (Dermatology)
GLOBAL EMPLOYMENT SOLUTIONS
03.2015 - 05.2015
Clinical Data Liaison (Oncology)
GLAXOSMITHKLINE
07.2013 - 03.2015
Clinical Scientist (Oncology)
MERCK & CO., INC.
03.2012 - 06.2013
Sr. Clinical Trial Specialist (Oncology)
AMGEN, INC.
11.2008 - 02.2012
Clinical Research Specialist (Oncology, Respiratory, Urology)
MERCK & CO., INC.
10.2006 - 10.2008
Clinical Program Associate II, (Medical Device, Oral Contraceptives)
DURAMED RESEARCH, INC.
12.2005 - 10.2006
In-house CRA (Osteoporosis)
COVANCE, INC.
07.2005 - 12.2005
Clinical Research Associate (Oncology)
FOX CHASE CANCER CENTER
03.2005 - 07.2005
Data Manager/Lead Study Coordinator (Oncology)
UNIVERSITY OF PENNSYLVANIA CANCER CENTER
06.2001 - 03.2005
B.A. - Psychology
Temple University