Sandra Paul
Clinical Team Manager
Wilmington,NC
Summary
Organized and dependable candidate successful at managing multiple projects/protocols with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Past experience in patient care and clinical research. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
20
20
years of professional experience
Work History
Clinical Team Leader
JnJ Ethicon
04.2022 - Current
- Responsible for leading one or several clinical trials within Ethicon Clinical Operations, as well as fostering strong productive relationships with colleagues across global organization
- Fostered staff development and competency through supervision, coaching, trainings and team meetings.
- Ensure all clinical and activities are carried out in compliance with Good Clinical Practices and applicable FDA regulations
- Serves as a member of the clinical study core team and may serve as the liaison with the Ethicon Franchise Clinical Team, Biostatistics and Data Management Team
- Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Track assigned projects budgets to ensure adherence to business plans
- Support the implementation of new clinical systems/processes, and provide support for publications, as needed
- Interface and collaborate with site personnel, IRBs/ECs
- Review and track monitoring visit reports
Clinical Trial Manager
Innovaderm Research, INC
09.2021 - 12.2021
- Oversight in Globally based Phase III dermatology clinical trials
- Review and tracking of clinical monitoring site trip reports (PSV, SIV, IMV, RemoteMON, COV)
- Conduct team and sponsor meetings
- Accountable for the clinical monitoring/site management delivery of assigned study(ies)
- Ensure studies are ICH-GCP and FDA regulations
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Clinical Team Lead
CATO SMS
12.2021 - 04.2022
- Coordinate and support site management and monitoring activities of investigational sites in North America and Europe
- Overseeing appropriate planning and tracking of monitoring visits and review of site visit reports
- Develop and maintain protocol related documents (Monitoring Plan, project operation manuals, Vendor information manuals, eDC completion guidelines)
- Providing CRA specific guidance, training and coaching
- Overseeing and managing site communications and siteissues to resolution
- Overseeing centralized monitoring and rick based monitoring activities
- Fostered staff development and competency through supervision, coaching, trainings and team meetings.
Clinical Team Manager
Syneos Health
01.2021 - 09.2021
- Review and tracked clinical monitoring site trip reports (PSV, SIV, IMV, RemoteMON, COV)
- Accountable for the clinical monitoring/site management delivery of assigned study(ies) including
Clinical Operations Lead
Parexel Inc
05.2010 - 10.2012
- Oversight of Global studies Phase III and IV Clinical Trials
- Received specific Manager Training
- Conducted Team training and maintained training records
- Provides leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of deliverables and achievement of financial goals
- Conducted CRA team meetings
- Participated in Kick Off Meetings
- Bid Defense meetings
Clinical Team Manager
Chiltern
10.2012 - 03.2019
- Oversight of Global Phase III and IV Clinical Trials
- Developed Monitoring Plan and eDC guidelines
- Trip report review (PSV, SIV, IMV, COV)
- Tracked site action items, site issues and subject safety information
- Mentor to Clinical Clinical Ops Managers, Research Associates (CRAs) and Clinical Trial Assistants (CTAs)
- Provide administrative line management, which includes oversight of training, compliance, performance and career management, and development of direct reports.
Clinical Team Manager
PPD Inc
02.2004 - 10.2008
- Phase II, III and IV Clinical Trials
- Tracked/maintained Study Timelines and budgets
- Developed Pharmacy Manual, Study Procedure Manual, Monitoring Plans, Vendor Management manuals
- Assisted with developing eDC UATs and eDC completion guidelines
- Trained and remain updated in vaious eData capture systems, CTMS, eTMFs and required integration systems
- Provided mentoring, and technical support to the Clinical Operations team to ensure quality sponsor deliverables
- Completed Monitoring visit reports reviews and applicable regulatory documents
- Monitored budget timelines
- Established and maintained effective communication with site staff promote high quality patient care.
Sr. Clinical Research Associate/CTM
AAI Pharma Research
11.2008 - 04.2010
- Oversight of Phase II, III and IV Clinical Trials
- Maintained, prepared and processed Regulatory Documents in Study StartUps
- Informed consent (ICF) development
- Managed Study Vendor: Central Laboratory and Patient Recruitment and Retention
- Complied and maintained Study Procedure Manual, Pharmacy Manual
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
Skills
- Operational Planning
- Quality Assurance Controls
- Executive Leadership
- Manage Operations
- Vendor Management
- Supplier Monitoring
- Organizational Structuring
- Professional Relationships
- Strategic Goals
- Inventory Tracking and Management
- Budget Controls
- Workflow Processes
- Microsoft Excel
- Microsoft PowerPoint
Accomplishments
- Association of Clinical Research Professionals certified since Nov/1997
- Outstanding American Women 1999
- Member of Wilmington Women's Service Club, INC., District 7 Chapter, Feb/2020
THERAPEUTIC EXPERIENCE
- Medical Surgical Device: Surgical wound closures Endomechanical staple line reinforcements, spiral knotless sutures, contour cutter/staple device, Renal stent placement (End stage renal failure
- Urology: Chronic Urinary Tract Infection (Phase III); Erectile Dysfunction (Phase IV), Overactive, Bladder (Phase II) BPA (Phase IV)
- Oncology: Oncology Pain, Glioblastoma Multiforme GBM? Relapse/Refractory Multiple Myeloma (Phase III)
- Respiratory: Asthma (pediatric and adult), Seasonal Allergic Rhinitis, Acute Pneumonia (Phase III);, Acute Exacerbation of Chronic Bronchitis (Phase IV)
- Antiviral/Vaccine: Neonatal RSV (Phase III), Covid (Phase III)
- Gastroenterology: Gastric and Duodenal Ulcer, Irritable Bowel Syndrome-c (Phase IV)
- CNS: Stroke, Epilepsy, Pain management (Phase III) Alzheimer, Parkinson's, Mold Dementia Phase IIa
- Dermatology: Atopic Dermatitis, Actinic Keratosis, Pseudofolliculitis Barbae, Burn Unit Oversight of cultured skin placement and skin debridement (Phase IV)
- Cardiovascular: Hypertension(Phase IV)
Education
University of Tennessee Center For Health Science
Memphis, TN Certification
- State Licensure Medical Technology Special Chemistry
- ACRP - CCRA
Timeline
Clinical Team Leader
JnJ Ethicon
04.2022 - Current
Clinical Team Lead
CATO SMS
12.2021 - 04.2022
Clinical Trial Manager
Innovaderm Research, INC
09.2021 - 12.2021
Clinical Team Manager
Syneos Health
01.2021 - 09.2021
Clinical Team Manager
Chiltern
10.2012 - 03.2019
Clinical Operations Lead
Parexel Inc
05.2010 - 10.2012
Sr. Clinical Research Associate/CTM
AAI Pharma Research
11.2008 - 04.2010
Clinical Team Manager
PPD Inc
02.2004 - 10.2008
University of Tennessee Center For Health Science
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