Jennifer H. Rowe
Waynesboro
Summary
I have 15 years of clinical research experience in roles specializing in Investigator Recruitment, Site Support, Study/ Site Start Up, Regulatory Document Review in the Clinical Trial Recruitment role, Project Management, Global and Local Trial Management (Feasibility through Close-Out) and Line Management (Local Trial Managers, Project Specialists, Clinical Research Associates, Clinical Trial Associates/Associate Clinical Project Managers). Outside of Clinical Research, I have held managerial positions with responsibility for hiring, training, supervision, program development and budget management. I also spent 11 years as an educator where I developed engaging presentation, problem solving, critical thinking, and facilitation skills.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Clinical Operations Manager- Dedicated Line Manager FSP Model
IQVIA
08.2024 - Current
- Manage staff (Clinical Research Associates and Clinical Trial Specialists/Associate Clinical Project Managers) in accordance with organization’s policies and applicable regulations
- Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems
- Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process
- Ensure that new employees are properly onboarded and trained
- Ensure that staff has the proper materials, systems access and training to complete job responsibilities
- Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training
- Manage the quality of assigned staff's clinical work through regular review and evaluation of work product
- Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff
- Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management
- May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service
- Participates in corporate or organizational departmental quality or process improvement initiatives
- Oncology Single Point of Contact for sponsor high priority/pivotal trials
SM Functional Manager- Cross TA (Line Manager- Late Development)
Johnson & Johnson Innovative Medicine
10.2019 - 08.2024
- Performed Line Management of Local Trial Managers and Clinical Research Associates
- Partnered with CRO FSP providers in management of Site Managers (CRAs)
- Managed oversight of staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports
- Managed alignment of local goals with organizational objectives
- Created innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/ Global Development (GD) overall
- Additional Leadership Roles: ADA Mental Health Diplomat, Anxiety Focus Group co-lead, SM Sharing Session Lead (Cross-TA and ONC), Provided support for iBOOST, an IBD corporate strategy initiative in collaboration with the Strategic Account Leads, Medical Science Liaisons and Feasibility Center of Excellence
- Immunology Single Point of Contact for Site Network Providers and Late Development Therapeutic Area
Sr. Clinical Team Manager, Sr. Local Trial Manager for Janssen Pharmaceuticals
PRA Health Sciences
02.2017 - 10.2019
- Led and managed assigned studies and clinical teams
- Planned and led execution of day-to-day activities for the monitoring of a clinical study and communicated consistently with the clinical team regarding project objectives, expectations and status updates
- Worked with the team to set priorities
- Ensured effective communication plans were in place for the clinical team
- Ensured effective escalation plans were in place for the clinical team
- Monitored the quality of clinical deliverables and addressed quality issues with appropriate team members
- Reviewed and approved site visit reports within agreed turnaround times and ensured tracking, follow- up and resolution of site issues
- Created and maintained project specific plans, documents, and tools for the clinical team
- Planned, performed oversight, and conducted initial and ongoing training for relevant study staff on assigned clinical projects
- Analyzed data related to site activation, monitoring, data retrieval and close out to identified issues and risks to clinical deliverables; developed contingency and mitigation plans to minimize risks; communicates risks mitigation strategies
- Supported the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable
- Ensured all PRA project reporting systems were up to date for clinical activities at the project level
Clinical Trial Manager
ICON plc- Full Service
07.2015 - 02.2017
- Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies
- Liaison between the Project Manager and a group of Clinical Research Associates (CRAs)
- Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders
- Responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g
- Implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; lP management, timely investigator payments
- Performed regular oversight of key clinical metrics including but not limited to: Days on Site (DOS), Monitoring Visit Report (MVR) and Follow up Letters (FUL) timelines, Action ltems (Al) and other quality metrics, to ensure they are met and followed-up as necessary
- Performed visit report review and approval, including site issue escalation and resolution
- Responsible for the development and maintenance of operational plans for clinical deliverables e.g
- CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc
- Ensured the core clinical portions of the Trial Master File (electronic or paper TMF) were up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary
Project Manager/Global Project Lead
INC Research
02.2012 - 06.2015
- Performed Project Management for full service, global clinical trials in Oncology
- Responsible for budget creation and management; Change Order Management
- Oversight of Vendor Management
- Responsible for line management of Project Specialists
Teacher
Waynesboro City Schools & Nelson County Public Schools
06.2001 - 02.2012
- Creatively design and deliver lessons which are grade-level appropriate and based upon the Virginia Department of Education’s Standards of Learning in math, social studies and reading
- Develop and implement assessments of curriculum for students
- Co-plan and co-teach with departmental peers and special educators and provide remediation services
- Communicate and coordinate interventions with child study committee members and parents to ensure students’ success and ability to access the curriculum in the regular education classroom
- Instruction Committee Chairperson and Summer School instructor; SAT proctor
Conference Services Manager
Wintergreen Resort
01.1999 - 01.2001
- Responsible for up-selling all offerings of the resort to groups, including accommodations, food & beverage, activities, recreation, audio-visual and transportation while assisting group meeting and event planners with the design and implementation of successful events at Wintergreen
- Acted as liaison between meeting planners and resort departments while professionally attending to all concerns and requests, during the planning stages and while the group is on-site
- Built favorable and lasting, long-term relationships with clients to generate future business and continued sales of service
- Secured vendors to provide additional services including florists, comedians, bands, bakeries, etc
Clinical Trials Recruiter, II
PRA Health Sciences
01.1997 - 01.1999
- Acted as the Lead Recruiter to identify and contact potential investigators and/or sites to participate in specific clinical trials
- QC reviewed and tracked all site regulatory documents and reconciled discrepancies with site staff with the goal of releasing investigational drug to sites promptly per FDA guidelines
- Ensured sponsor and investigator obligations were met and were following FDA regulatory requirements and Good Clinical Practices
- Mentored, trained and supervised junior recruiters while working on multiple, on-going trials
- Utilized and maintained the Investigator Recruitment Information System (IRIS) database, designed for accurate and efficient investigator recruitment and regulatory document tracking
- Coordinated and scheduled Pre-Study Site Visits (PSSVs) and Initiation Visits
- Interacted with and updated sponsors on the status of investigator recruitment and site start-up activities
Children's Program Manager
Wintergreen Resort
03.1995 - 08.1997
- Managerial responsibilities included recruiting, interviewing, hiring, training, supervising and scheduling counselor (~20) and supervisory staff (2) holding annual and seasonal positions
- Budgetary responsibilities included formulating fiscal and capital budget narratives, proposals, worksheets, and labor hour explanations
- Licensing responsibilities required a working knowledge of the licensing standards for the state of Virginia and compliance with those standards in the children’s program operations
- Programming responsibilities required writing and designing brochures, flyers, posters and other publicity needed to commercialize the program
Education
Bachelor of Science (B.S.) - Psychology and Elementary Education
William & Mary
Honor Graduate- Salutatorian -
Nelson County High School
Skills
- GCP
- Clinical Trials
- CTMS
- EDC
- CRO
- Regulatory Requirements
- Operations Management
- Vendor Management
- People Leader
- Risk Management and Mitigation Strategies
Certification
ICH/GCP Exam, 08/01/24
Awards
Finalist, Clinical Researcher of the Year, CTM Role- The Americas - Pharmatimes, 03/01/18, 04/01/19, 04/01/20
Therapeutic Experience
- Oncology, I-3, Soft Tissue Sarcoma, Melanoma, Acute Promyelocytic Leukemia, Lung, non-small cell Lung, Ovarian, Pancreatic, Solid Tumors, Clinical Trial Recruiter, Clinical Trial Manager, Project Manager, Line Manager
- Stroke, I-3, Acute Ischemic, Clinical Trial Recruiter
- Nutrition/Metabolism, 1, Infant Nutrition, Clinical Trial Recruiter
- Infectious Diseases, 1, MRSA, VRE, Clinical Trial Recruiter
- Immunology, 1-3, IBS-C, UC, CRD, Clinical Trial Manager, Local Trial Manager, Line Manager
- Neuroscience, 3, Treatment Resistant Major Depressive Disorder, Peds MS, Local Trial Manager, Line Manager
Timeline
Clinical Operations Manager- Dedicated Line Manager FSP Model
IQVIA
08.2024 - Current
SM Functional Manager- Cross TA (Line Manager- Late Development)
Johnson & Johnson Innovative Medicine
10.2019 - 08.2024
Sr. Clinical Team Manager, Sr. Local Trial Manager for Janssen Pharmaceuticals
PRA Health Sciences
02.2017 - 10.2019
Clinical Trial Manager
ICON plc- Full Service
07.2015 - 02.2017
Project Manager/Global Project Lead
INC Research
02.2012 - 06.2015
Teacher
Waynesboro City Schools & Nelson County Public Schools
06.2001 - 02.2012
Conference Services Manager
Wintergreen Resort
01.1999 - 01.2001
Clinical Trials Recruiter, II
PRA Health Sciences
01.1997 - 01.1999
Children's Program Manager
Wintergreen Resort
03.1995 - 08.1997
Bachelor of Science (B.S.) - Psychology and Elementary Education
William & Mary
Honor Graduate- Salutatorian -
Nelson County High School