Terry Stewart
Wheatley Heights,NY
Summary
Professional Project Management Specialist with experience working with teams to manage small scale and global clinical trials. Monitor budget, project costs and forecasting
Overview
18
18
years of professional experience
Work History
Project Director
Precision for Medicine
03.2021 - 05.2023
- Serve as the Subject Matter Expert (SME) for assigned projects
- Develop and maintain good working relationship with the sponsor including evaluating needs, resources, timelines, and budgets
- Oversee and manage all aspects of clinical trial for various clients and indications
- Manage study budgets and monthly forecasting ensuring project remains within scope and any out-of-scope activities are captured via Change Order
- Communicate with and manage relationships with internal and external clients, customers, team members, and other stakeholders
- Author study documentation, create reports, and present information in a timely manner as requested by internal and external stakeholders
- Prepare project status updates for clients and the Precision Executive Team, including notification of any deviations, and necessary actions in response to issues
- Enforce GMP/GLP/ISO/CLIA/Global regulations and standards within all aspects of the department and overall project execution
- Oversee 25+ projects simultaneously without sacrificing standards
- Provide direct oversight, management and follow up on assigned projects for direct reports
- Provide recommendations and guidance to escalated issues from direct reports
- Organize meetings with direct reports in order to conduct a mutual feedback session, focused on development and goal-setting consistent with company expectations
- Identify any performance problems and ensure an operational corrective action is taken
- Mentor Associate PMs to develop time management skills, improve client communications, lessons learned and general coaching
- Manage workload of supervised staff with continued assessment and adjustment as needed
Senior Project Manager
Q2 Lab Solutions
04.2016 - 02.2021
- Develop start-up plans including but not limited to project monitoring and communication plan, milestone and timelines tracking, risk management
- Global PM Lead for 20+ projects
- Participate in proposal development process, lead bid defense presentations in partnership with Business Development Team
- Collaborate with other functional groups to support milestone achievements
- Identify service level issues, proactive development of contingency plans to mitigate laboratory risk
- Ensure lessons learned are considered and implemented
- Prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings
- Provide additional training to sponsor, CRO, and site personnel as required
- Participate in external and internal audits
- Direct, mentor and train Project Services staff as needed.
Project Manager
PPD Labs
08.2015 - 04.2016
- Review clinical study protocol, vendor statement of work and biospecimen study sections
- Work closely with clinical teams to develop and implement biospecimen management plan for client-sponsored clinical trials
- Develop and execute asset and protocol-level biospecimen strategies to implement and project manage efforts to execute these strategies
- Provide innovative solutions to oversee timelines for specimen data delivery and ensure quick decision-making to various client requirements
- Oversee and manage the complete life cycle of biospecimens collected for Early or Late phase clinical studies with minimal supervision
- Provide shipping/sample movement and management including requests, query, and inventory reports, follow up active issue with vendors, prepare sample management related reports, review/prepare tracking activities such as vendor manifests/inventories
Project Manager
ICON Central Labs
04.2012 - 08.2015
- Manage the daily activities of the project management team to ensure client satisfaction by acting as the main point of contact for the client in all matters regarding the laboratory
- Act in an advisory role to team members
- Manage multiple clinical trials simultaneously including presenting at Investigator Meetings, implementing protocol amendments, participation in audits, bid defenses and trial reconciliation
- Following up and responding to study specific inquiries from Sponsor, CRO, Site or Vendors
- Provide Sponsor with study management reports and monitor study budget
Supervisor Client Support and Metrics
ICON Central Labs
02.2005 - 04.2012
- Manage global staff (Farmingdale-NY, Dublin-Ireland, Bangalore-India) in accordance with established guidelines, quality standards and SOP requirements
- Support delivery and development of clinical study related reports as well as analysis and interpretation of data
- Contribute to development and optimization of metrics and analytics to enhance output of client deliverables including Client-facing MCC Metrics
- Subject Matter Expert and trainer for new software
- Performance reviews and mentoring
Education
Bachelor of Science - Liberal Arts
Excelsior University
Albany, NYSkills
- Schedule Management
- Project Scopes
- Progress Tracking
- Interdepartmental Cooperation
- Client Relations
- Corrective Actions
- Process Improvement Initiatives
- Resource Forecasting
Accomplishments
- Solid Tumor Configuration
- Skin Infection
- Leukemia
- Dry Eye
- Malignant Melonoma
- Non-Small Cell Lung Cancer
Timeline
Project Director
Precision for Medicine
03.2021 - 05.2023
Senior Project Manager
Q2 Lab Solutions
04.2016 - 02.2021
Project Manager
PPD Labs
08.2015 - 04.2016
Project Manager
ICON Central Labs
04.2012 - 08.2015
Supervisor Client Support and Metrics
ICON Central Labs
02.2005 - 04.2012
Bachelor of Science - Liberal Arts
Excelsior University