Tracey Roberts
Holly Springs,NC
Summary
Executive leader with deep experience in driving organizational success with a proven track record in strategic planning, innovative problem-solving, clinical development, and program management. Expert in enhancing client relationships with strong interpersonal skills, a results-driven approach, demonstrated by leading over 40+ trials and a high RFP volume. Known for adaptability, resilience and delivering results in evolving environments. Skilled in project delivery and fostering team engagement, significantly growing market share in Ophthalmology.
Overview
22
22
years of professional experience
Work History
Executive Director, Project Delivery
PPD, Part of Thermo Fisher Scientific
04.2014 - Current
- Provide executive level oversight, subject matter expertise, and leadership of the Ophthalmology book of business as the Ophthalmology Pillar Head, including Ophthalmic strategic leadership and guidance for project delivery to ensure on time delivery of projects.
- Develop business plan to increase hit rates, viability, and market share for the pillar to continue to grow the book of business.
- Oversee executive level management of over 40+ trials to meet operational and financial targets for the Book of Business, ensuring fiscal responsibility and long-term sustainability for the organization and for clients.
- Chair critical risk level meetings for trials to support resolution in study/portfolio level risks.
- Provide direct line management for 8 directors and Senior directors (including 2 Pillar deputies). Guide staff through periods of organizational change, maintaining morale and engagement during transitions.
- Forge strong relationships with sponsors as Executive Sponsor, leading in governance meetings, engaging to support in escalations, risk mitigation, and strategic clinical development planning.
- Provide updates on the Book of Business to Executive levels and present at executive level meetings on risks.
- Lead initiatives to continue to be CRO of choice within Ophthalmology. Development of a site network, therapeutic area training plan, build focused vendor relationships, recruitment/retention strategies, active digital solutions with a site and patient centric focus. In addition, support a marketing plan with social platform outreach, webinars, conference, and article development.
- Lead proposal development strategies, capability meetings, Bid defenses as subject matter expert/Executive sponsor for an RFP volume yearly of over 500M+. Inclusive of indications in rare disease, cell/gene therapy, Dry Eyes, Glaucoma, and retina.
Sr.Director/Associate Director/Sr. Project Manager
PPD Development
02.2007 - 03.2014
- Responsible for the overall coordination and management of global clinical trials from start up through close out.
- Served as a Global Project Manager and/or Oversight Director for studies in Age Related Macular Degeneration, Diabetic Macular Edema, Inherited Retinal diseases, Retinopathy of Prematurity, Uveitis, Geographic Atrophy, Conjunctivitis, and Dry Eyes.
- Managed global study timelines/enrollment, progress of country approvals, status of site activations, vendor certifications/deliverables, site monitoring (including contract CRAs), and EDC data collection.
- Created effective risk management plans to ensure study timelines/enrollment were met per the original contracts even after significant regulatory delays.
- Implemented contingency plans after significant local IRB and contract delays. Including strategies to ramp subject enrollment.
- Collaborated with the sponsor, data management and medical writing to develop a Dry Eye Phase II protocol and EDC CRF. Managed a dry eye compound through Pre-IND preparations/FDA discussions and development of a multi-study strategy from Pre-clinical to Phase II.
- Provided senior management oversight for three Retinal Vein Occlusion studies, Geographic Atrophy Study, Wet AMD study, cold study, and asthma study.
- Provided guidance and risk management strategies for achieving database lock timelines (CRFs, queries, reading center images).
- Worked with team leads in all functional areas (clinical trial managers, data managers) to ensure clear team communication and processes.
- Mentored less experienced project managers regarding study budgets/finances, PPD processes, and risk management.
- Oversaw project specific training for project team members. Analyzes costs, personnel hours and project needs to determine the most cost effective and efficient means to ensure that all project deliverables meet the client’s needs and adhere to the contract.
Medical Program, Clinical Specialist
Merck & Company
03.2004 - 01.2007
- Managed and led all aspects of one or several Phase IIa through Phase IV clinical trials in the therapeutic area of Cardiovascular/Atherosclerosis.
- Managed large clinical outcome study using a CRO. Developed and wrote protocols and Clinical Study Reports.
- Tracked and monitored study enrollment and timelines.
- Planned and presented domestic and international Investigator Meetings.
- Medical review and monitoring of all clinical study data and lab data.
- Reported and monitored all clinical adverse experiences (Serious and Non-Serious).
- Collaborated with data management to create CRFs, DRMPs, DEGs, and DHGs.
- Selected investigative sites and primary investigators.
- Ordered, monitored, and tracked drug supplies.
- Communicated with field monitors to solve study related site problems and attend site visits when needed.
- Managed sites to ensure protocol and GCP compliance.
- Tracked study timelines and enrollment goals.
- Co-Authored PSUR, NDA, and IND Annual updates for specific programs.
- Provided in depth quarterly safety updates for an entire program.
- Trained & mentored new hires and colleagues on specific tasks.
- Worked with various functional groups, such as, regulatory, marketing, clinical supplies, statistics, and data management.
Clinical Utilization/Clinical Research Associate
Advanced Biologics
01.2003 - 03.2004
- Provided project-specific support as primary contact for all CRAs.
- Assisted with the administration of the conduct of approximately 4- 5 clinical trials. Tracked status of project(s) and flow of information associated with Regional Team. Discharged various project-specific responsibilities as support personnel.
- Performed project tracking (CRF, Subject tracking, Budget Metrics.
- Implemented, prepared, and designed CRA reference manuals, guidelines, and training manuals.
- Assisted regional team at sites regarding project issues. Tracked project budgets for individual studies (expense totals, monitoring totals).
- Conducted site Visits (Prestudy, Initiation, Monitoring, and Study Completion).
- Contributed to the training of newly hired personnel, including Clinical Research Associates.
- Conducted interviews and phone screens for new regional CRAs.
- Implemented new reports for Advanced Link (Clinical Trial Tracking System) Safety Associate (Part-time) to help meet project timelines for large pharmaceutical company (January 2004- June 2004).
- Processed and reviewed non-serious post market adverse events. Coded indications, diseases, and medical events in MEDRA. Responsible for follow-up letters for all US cases.
Medical Data Coordinator
Pfizer
07.2002 - 01.2003
- Processed clinical trials and adverse events to meet FDA regulations in a timely fashion.
- Performed quality reviews and troubleshooting procedures to minimize error and ensure quality of data provided for FDA review.
- Gained proficient knowledge in the use of the safety and tracking databases.
- Maintained a team environment to accomplish tasks promptly and effectively. Worked with six different therapeutic teams.
Education
Master of Science - Health Sciences
George Washington University
Washington, DC01-2005
Bachelor of Science - Biology
Radford University
Radford, VA01-2002
Skills
- Program management
- Strategic planning
- Project/Clinical management
- Strategic feasibility
- Proposal strategy/writing
- Patient recruitment
- Business Development Plans
- Project Plans
- Analyzing Data
- Client Relationships
Clinical Trial Experience
Ophthalmology Age Related Macular Degeneration, Geographic Atrophy, Retinal Vein Occlusion, Uveitis, Diabetic Macular Edema, Dry eyes, Cataracts, ROP, Inherited Retinal Diseases, Glaucoma (1yr), Stargardt Disease, Ocular Melanoma
Respiratory: Bronchopulmonary Dysplasia (6 mo), Sinusitis (1yr), Asthma (1yr)
Cardiovascular/Metabolic: Atherosclerosis (2yrs), Hypertension (2yrs)
Neuroscience: Dementia (1yr)
Professional Development
- Executive Presence Training- 2024
- PPD Gene Therapy Academy, 2023
- Completion of Ophthalmology Training Modules/Foundation Courses- 2015-2024
- Yearly attendance at Ophthalmology conferences including AAO, OIS, ARVO.
- Facilitative Leadership-WD Communications- 2006
- Powerful Presentations- Partner Communications- 2006
- High Impact Business Writing: Richard Pinsky Associates- 2005
- Scientific Writing & Editing: WD Communications- 2005
- Speaking Effectively: To One or One Thousand – Partner Communications- 2005
- Medical Terminology: Corexcel/Merck & Co. Inc.- 2004
- Adverse Event (Safety) Training: Johnson & Johnson Pharmaceuticals- 2004
- Foundations of Clinical Research/ CRA; Barnett/Parexel-2003
- CRA Self Training Series; Barnett/Parexcel- 2003
Timeline
Executive Director, Project Delivery
PPD, Part of Thermo Fisher Scientific
04.2014 - Current
Sr.Director/Associate Director/Sr. Project Manager
PPD Development
02.2007 - 03.2014
Medical Program, Clinical Specialist
Merck & Company
03.2004 - 01.2007
Clinical Utilization/Clinical Research Associate
Advanced Biologics
01.2003 - 03.2004
Medical Data Coordinator
Pfizer
07.2002 - 01.2003
Master of Science - Health Sciences
George Washington University
Bachelor of Science - Biology
Radford University
Similar Profiles
Skylar ReedSkylar Reed
Sr. Automation Specialist, Service at PPD, Part of Thermo Fisher ScientificSr. Automation Specialist, Service at PPD, Part of Thermo Fisher Scientific
Allary MbuakiAllary Mbuaki
FSP Clinical Research Associate for GSK at PPD part of Thermo Fisher ScientificFSP Clinical Research Associate for GSK at PPD part of Thermo Fisher Scientific
Amanda Flores, PharmDAmanda Flores, PharmD
Med Info Specialist II/Lead Product Champion at PPD, Part Of Thermo Fisher ScientificMed Info Specialist II/Lead Product Champion at PPD, Part Of Thermo Fisher Scientific