Tracy Comeaux
Olathe
Summary
Results-driven Senior Executive with a proven history of accelerating organizational success through strategic leadership and operational excellence. Expert at uniting cross-functional teams, driving complex projects, and fostering stakeholder relationships in fast-paced environments. Recognized for decisive leadership, effective communication, and a commitment to exceeding goals while navigating competing priorities.
Overview
24
24
years of professional experience
Work History
Senior Manager, Trial Management
Novo Nordisk Inc. (Remote)
Princeton, NJ, USA
03.2018 - Current
- Leadership of assigned Trial Management Teams (TMTs)
- Responsible to represent North America with HQ at the International Study Group (ISG) level.
- Set objectives of the project team according to agreed strategy and approach optimizing speed, quality and cost in compliance with standard process, policies and procedures.
- Collaborates with Business Management (BM) function to ensure the US trial budget is developed and managed in line with organizational expectations, including the development of appropriate site-level contracts and budgets.
- Accountable for all aspects of vendor management for assigned studies as needed/required. Ensure activities in accordance with contracted terms.
- Responsible for all project timelines and deliverables.
- Evaluates and communicates the probability and impact of risks
- Develops quality and risk management plans for performance and ensures this is integrated into the overall plan for the monitoring management project deliverables in accordance with project plan.
- Leads the activities relating to the execution of the Audit Management Plan for assigned studies.
- Participates in Health Authority (eg, FDA) inspections when necessary.
- Ensures local protocol amendments are written and submitted in a timely manner in accordance with SOPs.
- Monitors recruitment and retention of trial subjects and takes appropriate actions to mitigate any challenges.
- Manages the overall trial planning and set-up including: protocol development and approval, eCRF or CRF development (as appropriate), vendor selection and management, trial-level budget management, coordination with Clinical Supplies, and any other appropriate functions as necessary.
- Oversees the site selection process in collaboration with the assigned CSL and feasibility team.
- Presents at Investigator Meetings as required.
- Remote
Senior Manager, Clinical Operations
Synteract (Remote)
Carlsbad, CA, USA
12.2009 - 03.2018
- Assigned to project work as needed.
- Manage CRAs/CSLs in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work.
- Delivers performance reviews and guiding professional development.
- Participates in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process.
- Conducts onboard training for new staff in conjunction with Human Resources and Learning and Development training programs.
- Assigns staff to clinical studies that are appropriate to their experience and training.
- Identifies quality risks/issues and creates 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.
Clinical Operations Manager
Synteract (Remote)
Carlsbad, CA, USA
08.2012 - 10.2016
- Responsible for the overall management, development, training and hiring of CRAs.
- Participated in department initiatives and resourcing.
- Served as the primary clinical point of contact for Client representatives and Synteract team members in order to ensure the timely initiation and completion of clinical trials.
Clinical Trial Manager
Synteract (Remote)
Carlsbad, CA, USA
12.2009 - 08.2012
- Clinical Lead responsible for the overall coordination of the CRA team and monitoring of daily activities to ensure the successful completion of clinical trials.
- Coordinated study specific training and other requirements for internal and external staff.
- Responsible for the overall management and development of a Clinical Operations employee.
Clinical Team Manager
PRA International (Remote)
Lenexa, KS, USA
08.2007 - 12.2009
- Responsible for the overall coordination of the CRA team and monitoring of daily activities to ensure the successful completion of clinical trials.
- Served as the primary clinical point of contact for Client representatives as well as PRA team members in order to ensure the timely initiation and completion of clinical trials.
- Performed the monitoring of clinical trials at investigative sites according to company/project SOP’s with adherence to Good Clinical Practice, ICH, FDA, and protocol guidelines
- Remote
Clinical Research Associate II
United BioSource Corporation
Kansas City, KS, USA
12.2006 - 08.2007
- Performed the monitoring of clinical trials at investigative sites according to company/project SOP’s with adherence to Good Clinical Practice, ICH, FDA, and protocol guidelines.
- Trained and mentored CRA Level 1 personnel.
Clinical Research Associate
Us Micron
Lenexa, KS, USA
08.2005 - 12.2006
- Performed the monitoring of clinical trials at investigative sites according to company/project SOP’s with adherence to Good Clinical Practice, ICH, FDA, and protocol guidelines.
Clinical Research Coordinator
Saint Francis Health System
Tulsa, OK, USA
03.2005 - 08.2005
- Coordinated and managed 15 oncology studies phase I – IV including preparation of new study applications, informed consent forms and IRB submissions.
Clinical Operations Specialist
PRA International
Lenexa, KS, USA
05.2003 - 03.2005
- Responsible for clinical study start-up activities and maintenance of study documents. Assists with tracking study progress and monitoring of clinical trials at investigative sites.
Project Associate
PRA International
Lenexa, KS, USA
05.2002 - 05.2003
- Managed project documents, plans and status reports
- Reconciled invoices and investigator grant payments.
- Mentored 10 Project Assistants.
Education
Bachelor of Arts - Management
Ottawa University
Skills
- Strategic Planning & Execution
- Cross-Functional Team Leadership
- Driving Team Engagement through Transparent (Positive) Communication
- Analytical Decision-Making and Problem Resolution
Therapeutic Experience
- Oncology: Acute Myeloid Leukemia (Phase II), Breast Cancer (Phase II), Colorectal Cancer (Phase II), Hepatic neoplasm malignant (Phase II), Non-small cell lung cancer (Phase II)
- Oncology: Cervix carcinoma (Phase IV)
- Cardiology: Atrial Fibrillation (Phase II), Congestive Heart Failure (Phase II), Hypertension (device), Cardiovascular Outcomes –Obese (Phase IIIb)
- Endocrinology: Type 1 & Type 2 Diabetes (Phase III, Phase IIIa and IIIb)
- Endocrinology: Growth Hormone Deficiency-(Phase II & IIIa)
- Gastrointestinal: Irritable Bowel Syndrome (Phase III), Ulcerative Colitis (Phase III)
- Gastrointestinal: Gastrointestinal Disorder (Phase II)
- Pulmonology/Respiratory: Asthma (Phase III), Bronchiectasis -non-cystic fibrosis (Phase III)
- Infectious Disease: Pneumonia-HAP/VAP (Phase III), Bacterial Infection (Phase III)
- Nephrology: Cystinosis (Phase IIIb)
Timeline
Senior Manager, Trial Management
Novo Nordisk Inc. (Remote)
03.2018 - Current
Clinical Operations Manager
Synteract (Remote)
08.2012 - 10.2016
Senior Manager, Clinical Operations
Synteract (Remote)
12.2009 - 03.2018
Clinical Trial Manager
Synteract (Remote)
12.2009 - 08.2012
Clinical Team Manager
PRA International (Remote)
08.2007 - 12.2009
Clinical Research Associate II
United BioSource Corporation
12.2006 - 08.2007
Clinical Research Associate
Us Micron
08.2005 - 12.2006
Clinical Research Coordinator
Saint Francis Health System
03.2005 - 08.2005
Clinical Operations Specialist
PRA International
05.2003 - 03.2005
Project Associate
PRA International
05.2002 - 05.2003
Bachelor of Arts - Management
Ottawa University