Rebecca Hinton
Parma
Summary
Dynamic leader with extensive experience at IQVIA, excelling in project management and strategic planning. Proven track record in enhancing operational efficiency and driving financial performance across 200+ clinical projects. Adept at cross-functional collaboration and contract negotiation, fostering strong client relationships to ensure project success and customer satisfaction.
Overview
14
14
years of professional experience
Work History
Director Clinical Project Management
IQVIA and its Affiliated Companies
01.2022 - Current
- Direct and manage a team of 24 Clinical Project Management staff of various levels, Project Coordinator through Associate Director, who manage or support complex Global studies and programs to ensure on-time quality delivery, resulting in strong financial performance and customer satisfaction.
- Led cross-functional teams to develop strategic initiatives for MedTech Department growth and organizational development
- Develop and successfully Drive Departmental Key Performance Indicators, and the trending and review process for our entire Clinical Portfolio (roughly 200 projects).
- Implemented data-driven strategies to enhance operational efficiency across teams and Projects.
- Directed resource allocation for entire US Project Management Team.
- Develop Standard Operating Procedures, and ensure training and compliance for direct reports.
- Directed the organization's daily operations, ensuring compliance with applicable laws and regulations.
- Recruited, trained, supervised, evaluated and mentored staff members.
- Facilitated collaboration between teams by encouraging open communication channels.
- Collaborated with senior leadership to set long-term objectives for the company.
- Established relationships with vendors and suppliers to secure favorable terms for materials or services.
- Cultivated strong relationships with customers leading to reduction or avoidance of foreseen concessions and an increase in repeated business.
- Coordinated activities with other Business Units to expedite work and improve collaboration.
- Assessed employee performance against established benchmarks or targets.
- Reviewed internal reports and identified areas of risk or potential cost savings.
- Promoted a culture of innovation and encouraged staff to contribute ideas.
- Implemented systems for tracking progress on key initiatives or projects.
- Negotiated high-value contracts with vendors and clients.
- Managed crisis situations to minimize impact on operations and reputation.
- Enhanced customer satisfaction through the development of service improvement initiatives - on a project level and across the business unit.
- Drove studies to successful completion as Director-level Operational Oversight.
Associate Director of Clinical Project Management
IQVIA and its Affiliated Companies
01.2020 - 12.2021
- Responsible for the direction and the performance of the US MedTech Project Management staff.
- Works with the MedTech leadership team to develop departmental strategic and divisional goals and action plans in concert with corporate goals.
- Guides staff, as needed, for goal completion.
- Assure appropriate transition of staff both into IQVIA MedTech and into new roles in the department securing transition documentation and assuring LMS documentation of all training at the departmental level.
- Provides required and supplemental training to staff.
- Provides ongoing feedback regarding staff performance and assesses performance at least annually with quarterly documented review of goals.
- Makes recommendations regarding salary adjustments.
- In conjunction with management, assists with developing, documenting, and updating internal and program processes such as SOPs, working practices, and related quality assurance forms.
- Responsible for identifying processes which need updating and escalating to the MedTech lead.
- Assists in developing budgets and is accountable for the profit/loss for the Project Management component of each project and the overall performance of the PM department.
- Responsible for building and maintaining positive client relationships.
- Ensures operational processes are maintained, projects are done within scope, and team members do not initiate in activities based on client request and not best practices.
- Supports Project Management staff in the successful management of individual project operational management with appropriate escalating to department heads, VP level Management or Executive Oversight as escalation is necessary.
- Employs not only corrective action, but staff mentoring to drive both project success and staff development.
- Supports Project Managers in developing operational strategies to ensure successful implementation/execution of every contracted study.
- Interacts with all levels of management regarding IQVIA’s operational processes to assure operationally effective and financially efficient implementation.
- Assures reporting line has project level plans and strategies in place to assure proactive study management.
- Assures direct line has implemented appropriate early warning systems of impending obstacles to the successful completion of the projects; analyzes or supports the analysis of information and develops/supports line development of innovative solutions to challenges.
- Supports Project Management staff in the management of individual project budgets assuring fiscally responsible management with appropriate reporting to VP level Management.
- Responsible for the direction and the performance of the Project Management staff as assigned.
Sr. Clinical Project Manager & Sr. Clinical Safety Manager
genae Americas
07.2019 - 01.2020
- Oversee and coordinate the start-up, progress and closure of projects to ensure high quality research.
- Maintain high knowledge of genae processes as well as medical (device) regulation to comply with business and market requirements.
- Maintain project timelines and control clinical research budgets in close cooperation with the client.
- Ensure consistency and accuracy of project deliverables (study documents, timesheets, filing) across the genae study teams (staff and consultants).
- Guide and support teams in handling complex and critical tasks to ensure adherence to project or strategic objectives.
- Maintain strong written and verbal communication to convey clear, complete and concise messages when interacting with internal and external (cross-functional) teams.
- Develop solid managerial skills to foster a healthy work environment for study teams and direct reports to grow within the organization.
- Represent the genae group at all times, especially when interacting with sponsors, vendors and investigational sites.
- Contribute to coaching, training and appraising initiatives to promote team and organization excellence and growth.
- Take lead and perform overall project management for trials requiring more than one (1) Clinical Project Manager (CPM).
- Support BD in bid meetings, budget estimations and project approaches.
- Be an expert and provide support towards new project management tools and clinical research approaches.
- Act as point of contact for Director Operation (DO) and Senior Management to discuss study issues and resolutions.
Clinical Project Manager & Clinical Safety Manager
genae Americas
08.2017 - 06.2019
- Oversee and coordinate the start-up, progress and closure of projects to ensure high quality research.
- Maintain high knowledge of genae processes as well as medical (device) regulation to comply with business and market requirements.
- Maintain project timelines and control clinical research budgets in close cooperation with the client.
- Ensure consistency and accuracy of project deliverables (study documents, timesheets, filing) across the genae study teams (staff and consultants).
- Guide and support teams in handling complex and critical tasks to ensure adherence to project or strategic objectives.
- Maintain strong written and verbal communication to convey clear, complete and concise messages when interacting with internal and external (cross-functional) teams.
- Develop solid managerial skills to foster a healthy work environment for members of their study teams to grow within the organization.
- Represent the genae group at all times, especially when interacting with sponsors, vendors and investigational sites.
- Contribute to coaching, training and appraising initiatives to promote team and organization excellence and growth.
Clinical Project Manager
genae Americas
09.2016 - 07.2017
- Oversee and coordinate the start-up, progress and closure of projects to ensure high quality research.
- Maintain high knowledge of genae processes as well as medical (device) regulation to comply with business and market requirements.
- Maintain project timelines and control clinical research budgets in close cooperation with the client.
- Ensure consistency and accuracy of project deliverables (study documents, timesheets, filing) across the genae study teams (staff and consultants).
- Guide and support teams in handling complex and critical tasks to ensure adherence to project or strategic objectives.
- Maintain strong written and verbal communication to convey clear, complete and concise messages when interacting with internal and external (cross-functional) teams.
- Develop solid managerial skills to foster a healthy work environment for members of their study teams to grow within the organization.
- Represent the genae group at all times, especially when interacting with sponsors, vendors and investigational sites.
- Contribute to coaching, training and appraising initiatives to promote team and organization excellence and growth.
Clinical Research Manager
Kennedy Krieger Institute/ Johns Hopkins Hospital
09.2015 - 09.2016
- Supervise a Multidisciplinary team of physicians, psychologists, nurses, psychology associates, research coordinators, phlebotomists, students, and volunteers.
- Create, monitor, and edit all SOPs for regulatory, training, and QA purposes.
- Guide, orient and fully train new staff, including Research Assistants, Research Coordinator I and II’s and students.
- Contract negotiation with pharmaceutical sponsors.
- Budget drafting, implementation, and maintenance.
- Complex, real-time problem solving when unexpected protocol deviations and events occur.
- Work closely with the Quality Assurance Coordinator to develop, implement and continuously monitor systems to ensure quality assurance procedures are followed by the department.
- Managed several simultaneous multi-center, global medical device and pharmaceutical clinical trials in the following therapeutic areas: Neurology, Sturge Weber Syndrome, Fragile X Syndrome, Bipolar Disorder, Tuberous sclerosis, Autism, Downs Syndrome, Anxiety, ADHD, Depression.
Lead Research Coordinator
Kennedy Krieger Institute/ Johns Hopkins Hospital
08.2013 - 09.2015
- Responsible for preparation of IRB required materials; as well as preparation of compliance and regulatory documentation for local (i.e., the IRB), state, and federal (e.g., FDA) agencies and any other pertinent entity (e.g., study sponsor).
- Responsible for coordinating day-to-day clinical trial activities.
- Responsible for research data management in accordance with protocols established by investigators or sponsors: data entry, transfer, archiving, maintenance, analysis.
Fragile X Clinic Manager & Research Coordinator
Kennedy Krieger Institute/ Johns Hopkins Hospital
09.2011 - 08.2013
- Responsible for preparation of IRB required materials and submission.
- Responsible for coordinating day-to-day clinical trial activities for 5 FXS clinical trials.
- Responsible for research data management in accordance with protocols established by investigators or sponsors: data entry, data transfer, data archiving, data maintenance, data analysis.
- Data analysis including performing statistical analyses, presentation of results, and initial data interpretation.
Education
Master of Science - Clinical Psychology
Loyola University Maryland
United StatesBachelor of Science - Psychology
University of Maryland
United StatesSkills
- Project management
- Clinical trial oversight
- Resource allocation
- Budget management
- Strategic planning
- Cross-functional collaboration
- Performance metrics and management
- Regulatory compliance
- Contract negotiation
- Crisis management
- Effective communication
- Process improvement
- Customer relationship management
- Organizational development
- Hiring and retention
- Financial management
- Financial analysis
Device Trial Experience
- Pivotal, Kidney Disease, 1, 5, 50, Associate Director, Study close out and archival
- Pivotal, Pre-Eclampsia, 1, 5, 13, Associate Director, Acting in capacity as Clinical Project Manager. Oversite of study start-up, enrollment, follow-up and close out. Oversight of study budget and team.
- Post market, Cardiovascular Disease, Interventional, III, 17, 76, 1500, Associate Director, Oversight of overall study execution, Clinical Project Management, and Safety Management.
- Pivotal, Ischemic Stroke, Senior Project Manager, On this study I acted as Senior Project Manager and Senior Safety Manager. I was responsible for maintaining the timeline, budget, and deliverables. Oversight of EDC and Data Management leads. Responsible for oversight of all safety related activities and staff, expedited and periodic reporting, (S)AE review and tracking, DSMB and CEC management and facilitation.
- Pilot, Heart Failure, Senior Project Manager, On this program of 3 studies (US, AU, EU) I acted as Senior Project Manager and Senior Safety Manager. I was responsible for maintaining the timeline, budget, and deliverables. Oversight of EDC and Data Management leads. Responsible for oversight of all safety related activities and staff, expedited and periodic reporting, (S)AE review and tracking, DSMB and CEC management and facilitation.
- Post market, Coronary Artery Stenosis, Senior Project Manager, On this study I acted as Senior Project Manager and Senior Safety Manager. I was responsible for maintaining the timeline, budget, and deliverables. Oversight of EDC and Data Management leads. Responsible for oversight of all safety related activities and staff, expedited and periodic reporting, (S)AE review and tracking, DSMB and CEC management and facilitation.
- Pilot, Atrial Fibrillation, Associate Director, Project Management, Operational oversight to Project Manager/ Project Team. First point of escalation for client.
- Pilot, COVID-19, Associate Director, Project Management, Operational oversight to Project Manager/ Project team. First point of escalation for client.
- Pivotal, HPV Infection, Associate Director, Project Management, Operational oversight to project managers/ project team. First point of escalation for client.
- Pivotal, Coronary Artery Stenosis, Senior Project Manager, On this study I acted as Senior Project Manager and Senior Safety Manager. I was responsible for maintaining the timeline, budget, and deliverables. Oversight of EDC and Data Management leads. Responsible for oversight of all safety related activities and staff, expedited and periodic reporting, (S)AE review and tracking, DSMB and CEC management and facilitation.
- Pivotal, Cataract, Director Project Management, Operational Oversight
- Pivotal, Traumatic Brain Injury, Director Project Management, Operational Oversight
- Post market, Osteoarthritis, Director Project Management, Operational Oversight
- Pivotal, Blood Coagulation Disorder, Director Project Management, Operational Oversight
- Pivotal, Diabetes Mellitus, Director Project Management, Operational Oversight
- Pilot, Postpartum depressive disorder, Director Project Management, Operational Oversight
- Pivotal, Aortic Thromboembolism, Director Project Management, Operational Oversight
- Pilot, COVID-19, Director Project Management, Operational Oversight
- Pilot, Atopic dermatitis, Director Project Management, Operational Oversight
- Pivotal, Ischemic Stroke, Director Project Management, Operational Oversight
- Pivotal, Schizophrenia
Job Title
Dir, Clin Project Mgmt
Business Title
Director, Project Management
Supervisor Name
Kelley Kennedy
Country Of Residence
United States
Regular Temp Status
Regular
Therapeutic Experience
- Neurology
- Fragile X syndrome, Study Coordinator, Research Manager
- Neuropathic pain, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Tuberous sclerosis syndrome, Study Coordinator
- Down Syndrome, Study Coordinator
- Psychiatry
- Anxiety Disorder, Study Coordinator, Research Manager
- Autistic Disorder, Study Coordinator, Research Manager
- Major Depressive Disorder, Study Coordinator, Research Manager
- Schizophrenia, Study Coordinator, Research Manager
- ADHD, Study Coordinator, Research Manager
- Cardiovascular
- Cardiovascular Disease, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Coronary Artery Stenosis, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Ischemic Stroke, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Atrial Fibrillation, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Heart Failure, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Dermatology
- Alopecia, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Orthopedics
- Fracture of Bone, Senior Project Manager; Senior Safety Manager; Associate Director, Clinical Project Management
- Women's Health / Sexual Health
- HPV Infection, Associate Director, Clinical Project Management
- Pre-Eclampsia, Associate Director, Clinical Project Management
Clinical Trial Experience
- Phase 3, Schizophrenia, Minors, Large, Large, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 3, Autistic Disorder, Minors, Large, Medium, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 3, Autistic Disorder, Minors, Large, Large, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 3, Schizophrenia, Minors, Large, Large, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 2, Down Syndrome, Small, Small, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment, Budgeting and invoicing
- Phase 3, Major Depressive Disorder, Minors, Large, Large, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment, Budgeting and invoicing
- Phase 2, Autistic Disorder, Large, Large, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment, Budgeting and invoicing
- Phase 4, Anxiety Disorder, Minors, Large, Large, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment, Budgeting and invoicing
- Phase 1, Schizophrenia, Small, Small, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 4, ADHD, Minors, Large, Large, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 2, Major Depressive Disorder, Minors, Medium, Medium, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment, Budgeting and invoicing
- Phase 2, Fragile X syndrome, Rare Diseases, Large, Large, Clinical Project Manager (CPM), Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment, Budgeting and invoicing
- Phase 1, Autistic Disorder, Minors, Small, Small, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 2, Fragile X syndrome, Rare Diseases, Medium, Medium, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 3, Autistic Disorder, Minors, Medium, Medium, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 3, Fragile X syndrome, Rare Diseases, Medium, Medium, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
- Phase 3, Fragile X syndrome, Rare Diseases, Large, Large, Clinical Project Coordinator, Endpoint assessment administration and scoring, IP reconciliation, IRB submissions and notifications, Patient recruitment
Timeline
Director Clinical Project Management
IQVIA and its Affiliated Companies
01.2022 - Current
Associate Director of Clinical Project Management
IQVIA and its Affiliated Companies
01.2020 - 12.2021
Sr. Clinical Project Manager & Sr. Clinical Safety Manager
genae Americas
07.2019 - 01.2020
Clinical Project Manager & Clinical Safety Manager
genae Americas
08.2017 - 06.2019
Clinical Project Manager
genae Americas
09.2016 - 07.2017
Clinical Research Manager
Kennedy Krieger Institute/ Johns Hopkins Hospital
09.2015 - 09.2016
Lead Research Coordinator
Kennedy Krieger Institute/ Johns Hopkins Hospital
08.2013 - 09.2015
Fragile X Clinic Manager & Research Coordinator
Kennedy Krieger Institute/ Johns Hopkins Hospital
09.2011 - 08.2013
Master of Science - Clinical Psychology
Loyola University Maryland
Bachelor of Science - Psychology
University of Maryland