Summary
Overview
Work History
Education
Skills
Created Date
Personal Information
Last Modified Date
Therapeutic Experience
Timeline
Generic

Tracy Topp

Windsor

Summary

Ms. Topp has 26 years of experience in clinical research, holding various roles such as Associate Director of Clinical Trial Management, Principal Central Monitor, Project Director, Project Manager, Clinical Team Lead, Field Monitor, and Study Coordinator across Phase I to IV drug studies. With education as a registered nurse this enhances her understanding of patient data and diseases. Therapeutic experience includes Oncology, Allergy & Asthma, Cardiovascular, Ophthalmology & COVID-19. Across these varied roles, she has significantly impacted the delivery of critical clinical trial work. Clinical Team Leader: Managed clinical operations, site management activities, and sponsor interactions. Project Manager: Led cross-functional teams, ensured timely and budget-compliant project deliverables, and mentored team members. Project Director: Ensured client consistency across studies and acted as a liaison between Syneos Health and sponsors. Principal Central Monitor: Develops Central Monitoring Dashboards, conducted Study Level Surveillance Reviews, and collaborated with multidisciplinary teams. Associate Director, Clinical Trial Management: Provides line management, mentorship, performance appraisals, and ensured utilization targets were met.

Overview

27
27
years of professional experience

Work History

Associate Director, Clinical Trial Management

Syneos Health
Toronto
06.2023 - Current
  • Provides expert monitoring strategy, oversight and guidance to support internal teams and Principal Central Monitoring team.
  • Includes defending the rationale for monitoring strategy, process and tools and maintaining current knowledge of industry trends and current-thinking.
  • Identifies needs and may make recommendations for process improvement and efficiencies.
  • Provides operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others.
  • Participates in committees and work groups to support the development and implementation of new initiatives and strategic direction of the BU and cross-BU Clinical Operations.
  • Line Management responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counseling of staff.
  • Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
  • Liaises with resourcing management on active awarded and proposal project assignments for the Principal Central Monitoring team.
  • Reviews workload, utilization, productivity, and quality for staff in reporting chain.
  • Manages the resource availability for the assigned staff, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.
  • Support the assessment of overall staff growth and actively participate in the selection and hiring process.
  • Proactively works to ensure staff retention and turnover rates remain within expected levels.
  • Ensures all staff follows required training and completes the required documentation.

Principal Central Monitor

Syneos Health
05.2020 - Current
  • Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
  • Reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity.
  • Immediately communicates/escalates serious issues to the project team and, with guidance, develops action plans.
  • Documents observations noted during reviews, investigates trends, issues and risks for root cause.
  • Creates action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.
  • Actively participates in initial risk assessments and suggest various anticipated study specific risks.
  • Reviews Monitoring Plan and suggest strategies.
  • Set-up and/or provide inputs needed for setting-up analytics tools.
  • Maintains expert knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
  • For assigned activities, understands project scope, budgets, and timelines; manages study and portfolio-level activities to ensure project objectives, deliverables and timelines are met.
  • Must be able to quickly adapt to changing priorities to achieve goals/targets.
  • Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings as applicable and attends clinical training sessions according to the project specific requirements.
  • Performs QTL reviews with support from cross-functional team, facilitates discussions on any mitigations or changes needed to functional plans. Responsible for tracking Quality Tolerance Limits reviews, results and mitigations.
  • Utilizes KRI dashboards, metrics and reporting systems and other analytical tools to synthesize data trends, issues, action items in a clear and concise presentation for actionable items by the Project Team and Sponsor.

Project Director

Syneos Health
03.2018 - 06.2020
  • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
  • Oversee a portfolio or program of projects.
  • Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
  • Represent company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
  • Ensures the study is progressing according to internal and Customer quality standards, SOPs, GCPs or appropriate regulatory requirements, and ICH guidelines to fulfil all federal and local regulations.
  • Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
  • Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
  • Apply study specific learning across assigned portfolio of studies/clients.
  • Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
  • May lead operational input to proposal development and pricing including proposed operations strategy.
  • Drive performance improvement, operational efficiencies and innovative strategies.
  • May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert.

Project Director I

Syneos Health
08.2016 - 03.2018
  • Acts as a primary liaison with the Customer to ensure study launch, conduct, and closeout according to the contractual agreement.
  • Coordinates project organization, implementation, and management activities between all Company operations and the client.
  • Manages the executed contract and financial aspects of assigned projects including reviewing study budgets and expenses.
  • Oversees the regulatory document collection and submission process and completion of the site and/ or trial master file.
  • Assists in the contracting process with outside vendors.
  • Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI).
  • Performs ongoing review of project financial status of studies.
  • Alerts senior management to potential issues and ensures necessary corrective action is taken.
  • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
  • Produces and distributes status, resourcing, and tracking reports as well as functional area plan to appropriate team members and senior management.
  • Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans.
  • Develops strong relationships with current and prospective clients to generate new and/or add-on business for the future.
  • Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports; ensures adequate documentation of each communication.
  • Independently prepares information for internal review meetings.
  • Presents prepared information at project review meetings.
  • Reviews and approves information from PMs for internal review meetings.
  • Networks to acquire new and/or repeat business. Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc.
  • Presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.
  • Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract.
  • Demonstrates mastery of current research environment and drug development trends and facilitates the development of knowledge for more junior staff.
  • Facilitates team training in accordance with protocol and/or project requirements including protocol specific, and process training.
  • May review protocol to ensure Sponsor's objectives are met and are in line with their Drug Development Program.
  • Manages a project as project manager. May manage more complex/larger global projects and/or programs. Acts as a liaison and facilitator between other departments to ensure project related tasks and/or issues are addressed.
  • Serves as team leader and actively line manages and mentors other project management roles.
  • Facilitates team building and communication. Plans and negotiates resources with line management of functional areas.

Senior Project Manager

INC Research
04.2016 - 08.2016
  • Ensures the contracted services and expectations of a clinical study are carried out by the INC Research (INCR) project team in accordance to the executed contract and the Customer's expectations.
  • Serves as project leader for assigned projects, which may range from single service studies to full scope or multiple protocol projects.
  • Duties include primary liaison with Customers, Vendors and/or Investigative Sites.
  • Line management responsibility for project management staff.
  • Manages the executed contract and financial aspects of assigned projects, including management of resources, tasks, risks, and quality.
  • Prompts and tracks site payments.
  • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
  • Develops and maintains project plans for the study. Generates and distributes status, resourcing, and tracking reports, and functional area plans to appropriate project team members and senior management.
  • Reviews study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed.
  • Therapeutic focus in Oncology since July 2005.
  • Mentoring of Project Specialists, Project Managers and CRAs.

Project Manager

INC Research
09.2011 - 03.2016
  • Prompts and tracks site payments.
  • Manages the executed contract and financial aspects of assigned projects, including management of resources, tasks, risks, and quality.
  • Ensures the contracted services and expectations of a clinical study are carried out by the INC Research (INCR) project team in accordance to the executed contract and the Customer's expectations.
  • Serves as project leader for assigned projects, which may range from single service studies to full scope or multiple protocol projects.
  • Duties include primary liaison with Customers, Vendors and/or Investigative Sites.
  • Line management responsibility for project management staff.
  • Reviews study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed.
  • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
  • Develops and maintains project plans for the study. Generates and distributes status, resourcing, and tracking reports, and functional area plans to appropriate project team members and senior management.
  • Therapeutic focus in Oncology since July 2005.
  • Mentoring of Project Specialists, Project Managers and CRAs.

Clinical Team Leader

INC Research
05.2010 - 09.2011
  • Developed and maintained project plans for the study in accordance with INC Research's SOPs and Work Instructions.
  • Therapeutic focus in Oncology since July 2005.
  • Generated and distributed status, resourcing, and tracking reports, and functional area plans, to appropriate project team members and senior management.
  • Served as Lead Clinical Research Associate (LCRA) and Project Lead (PL) while in the title of Clinical Team Leader.
  • Primary responsibility as LCRA was site management and performance, including documentation. Site management activities include supervision of all in-house and on-site monitoring for all visit types.
  • Responsible for training, management and coordination of Clinical Research Associates (CRAs) on clinical research projects.
  • Managed personnel and processes to ensure timely site activation and trial progress.
  • Evaluated data trends to optimize CRA monitoring practices and disseminate education to site teams.
  • Primary responsibility as Project Leader was to liaise with customer to ensure progress with study launch, conduct and closeout according to the contractual agreement and according to quality standards, SOPs, GCPs and ICH guidelines.
  • Reviewed study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed.
  • Prompted and tracked site payments.
  • Managed projects ranging in size and complexity from single services studies to full scope projects with supervision from project director, including management of resources, tasks, risks, and quality.
  • Maintained effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensuring adequate documentation of each communication.
  • Served as primary liaison with outside vendors such as laboratories, printers, drug packaging, labelling and storage, and Interactive Voice Response System (IVRS) companies.

Senior Clinical Research Coordinator

INC Research
05.2004 - 05.2010
  • Managed projects ranging in size and complexity from single services studies to full scope projects with supervision from project director, including management of resources, tasks, risks, and quality.
  • Primary responsibility as LCRA was site management and performance, including documentation. Site management activities include supervision of all in-house and on-site monitoring for all visit types.
  • Responsible for training, management and coordination of Clinical Research Associates (CRAs) on clinical research projects.
  • Generated and distributed status, resourcing, and tracking reports, and functional area plans, to appropriate project team members and senior management.
  • Developed and maintained project plans for the study in accordance with INC Research's SOPs and Work Instructions.
  • Therapeutic focus in Oncology since July 2005.
  • Managed personnel and processes to ensure timely site activation and trial progress.
  • Maintained effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensuring adequate documentation of each communication.
  • Primary responsibility as Project Leader was to liaise with customer to ensure progress with study launch, conduct and closeout according to the contractual agreement and according to quality standards, SOPs, GCPs and ICH guidelines.
  • Evaluated data trends to optimize CRA monitoring practices and disseminate education to site teams.
  • Served as Lead Clinical Research Associate (LCRA) and Project Lead (PL) while in the title of Senior CRA.
  • Reviewed study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed.
  • Prompted and tracked site payments.
  • Served as primary liaison with outside vendors such as laboratories, printers, drug packaging, labelling and storage, and Interactive Voice Response System (IVRS) companies.

Clinical Research Associate

MDS Pharma Services
12.2001 - 05.2004
  • To ensure that investigators are aware of their responsibilities and the need to comply with ICH GCP and appropriate company/Sponsor procedures and all other local regulatory requirements.
  • Conduct site visits including PSSV, SIV, IMV and COV.

Clinical Research Coordinator

Toledo Center for Clinical Research
06.2000 - 12.2001
  • Duties included coordinating patient visits for clinical trials on investigational medications, knowledge of federal regulations relating to clinical trials.
  • Maintaining documentation of patient participation & carrying out protocol procedures.
  • Filing and maintaining all regulatory forms.

Clinical Research Nurse

Acute Care Research Group
01.1999 - 05.2000
  • Duties included coordinating and assisting with documentation of patient participation, carrying out protocol procedures, filing and maintaining all regulatory forms.

Education

Bachelor of Science in Nursing - Registered Nurse

Laurentian University

Skills

  • Cancer
  • Pharmacokinetic
  • Dose Escalation
  • First in Human
  • IMPACT Experience
  • Investigator Initiated Trials
  • Patient Reported Outcomes
  • Phase 1 - Healthy Subjects
  • Retrospective Chart Reviews (RCR)
  • Risk Based Monitoring
  • Risk Management Plans
  • Tolerability
  • Cluepoints
  • EDC-Other
  • Integrated data review
  • Laboratory Normal Ranges management
  • PRO-CTCAE
  • Paper CRF
  • Power BI
  • Quality of Life Experience
  • Spotfire
  • Spotfire UAT
  • Statistics
  • EPRO
  • Risk assessment
  • Project oversight
  • Process improvement
  • Budget management
  • Clinical trial management
  • Stakeholder communication
  • Resource allocation
  • Performance evaluation
  • Leadership development
  • Team collaboration
  • Problem solving
  • Attention to detail
  • Effective mentorship
  • Performance evaluations
  • Coaching and mentoring
  • Database development
  • Decision-making
  • Analytical thinking
  • MS office
  • Reporting and documentation
  • Onboarding and training
  • Team collaboration and leadership
  • Project management
  • Resources allocation
  • Operations management
  • Critical thinking
  • Staff management

Created Date

01/01/25

Personal Information

Title: Assoc Dir, Clinical Trial Mgmt- Central Monitoring

Last Modified Date

07/06/25

Therapeutic Experience

  • Oncology, Blood & blood forming malignancies, General blood malignancies
  • Cardiovascular, Ischemic heart disease, Angina, unstable

Timeline

Associate Director, Clinical Trial Management

Syneos Health
06.2023 - Current

Principal Central Monitor

Syneos Health
05.2020 - Current

Project Director

Syneos Health
03.2018 - 06.2020

Project Director I

Syneos Health
08.2016 - 03.2018

Senior Project Manager

INC Research
04.2016 - 08.2016

Project Manager

INC Research
09.2011 - 03.2016

Clinical Team Leader

INC Research
05.2010 - 09.2011

Senior Clinical Research Coordinator

INC Research
05.2004 - 05.2010

Clinical Research Associate

MDS Pharma Services
12.2001 - 05.2004

Clinical Research Coordinator

Toledo Center for Clinical Research
06.2000 - 12.2001

Clinical Research Nurse

Acute Care Research Group
01.1999 - 05.2000

Bachelor of Science in Nursing - Registered Nurse

Laurentian University

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Tracy Topp