Jaime Birt
Raleigh
Summary
Experienced clinical operations leader with 10+ years of experience in Phase I-IV clinical research trials with emphasis on rare disease, autoimmune disease, gastrointestinal diseases, ophthalmology and various central nervous system disease indications. Excellent reputation for problem-solving, analytical thinking, transparent communication, team leadership, strategic planning and driving overall operational improvements.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Associate Director Clinical Trial Management
Syneos Health
06.2022 - Current
- Oversee clinical study management, strategy, scope of work and budget for a portfolio of global studies
- Leverage data and analytics to make informed decisions and drive business improvements.
- Prioritizes tasks and allocates resources appropriately to keep teams focused and productive.
- Successfully manages budgets and allocated resources to maximize productivity and profitability.
- Lead team of up to 25 Clinical Trial Managers, supervising daily performance as well as training and improvement plans.
- Primary point of contact for clients for all clinical escalations
- Contribute in the preparation of clinical documents and tools (i.e., Clinical Monitoring Plan, Site Operational Plans, Safety Management Plan)
- Monitor and analyze clinical study performance metrics
Director of Clinical Operations
Lightship, Inc
11.2021 - 04.2022
- Directed and trained project managers
- Oversaw and streamlined the onboarding process for new hires
- Oversaw all project-related deliverables
- Prepared, organized and presented project updates to the executive leadership team
- Negotiated and managed clinical budgets
- Directed multiple vendors to align study deliverables and milestones
- Crafted department Standard Operating Procedures
- Crafted tools and processes to streamline multiple departments
- Conducted pitch calls to invite investigators into the Lightship physician network
- Collaborated with clients on protocol design for full decentralization or hybrid decentralization
Associate Clinical Lead Director
IQVIA
06.2021 - 10.2021
- Managed the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-
database lock) of a large clinical trial or multiple smaller trials in accordance with project-specific needs, assumed Lead/Global CTM responsibilities - Managed multiple vendors to align study deliverables and milestones
- Managed clinical budget and all forecasting and revenue recognition
- Liaised the with Clinical Manager - CRA regarding current CRA metrics; focus on quality improvements and milestone objectives
- Managed risks and contingency planning for data cleaning; clinical data listings review; coordinated process for reviewing data listings by a clinical team; escalate quality issues
recognized; and provided CRA retraining for quality data as needed - Participated in site recruitment planning and provided contingency planning for site recruitment milestones
- Prepared, organized and presented at Investigator Meetings
Principal Clinical Trial Manager
Thermo Fisher (Formerly PPD, Inc)
06.2015 - 05.2021
- Managed and operationalized Digital Clinical Trials (DCT) for COVID-19 platform trials for government and commercial sponsors
- Contributed to the development of Clinical Study Reports
- Managed the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a large clinical trial or multiple smaller trials
in accordance with project-specific needs, assumed Lead/Global CTM responsibilities - Managed multiple vendors to align study deliverables and milestones
- Managed clinical budget
- Liaised with Clinical Manager - CRA regarding current CRA metrics; focus on quality improvements and milestone objectives
- Managed risks and contingency planning for data cleaning; clinical data listings review; coordinated process for reviewing data listings by a clinical team; escalate quality issues
recognized; and provided CRA retraining for quality data as needed - Participated in site recruitment and provided contingency planning for meeting site recruitment milestones
- Prepared, organized and presented at Investigator Meetings and Study Kick off Meetings
- Mentored new CTMs and assisted with onboarding
- Responsible for setting up, implementing and maintaining clinical study documents, training and clinical processes to ensure efficiencies and consistency across all regions.
Clinical Manager
Premier Research
09.2013 - 05.2015
- Managed the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a large clinical trial or multiple smaller trials in accordance with project-specific needs, assumed Lead/Global CTM responsibilities
- Managed multiple vendors to align study deliverables and milestones
- Managed clinical budget
- Liaised with Clinical Manager - CRA regarding current CRA metrics; focus on quality improvements and milestone objectives
- Managed risks and contingency planning for data cleaning; clinical data listings review; coordinated process for reviewing data listings by a clinical team; escalate quality issues recognized; and provided CRA retraining for quality data as needed
- Participated in site recruitment and provided contingency planning for meeting site recruitment milestones
- Prepared, organized and presented at Investigator Meetings and Study Kick off Meetings
Clinical Trial Manager
Novella Clinical
10.2012 - 09.2013
Clinical Trial Manager
PRA International
10.2010 - 10.2012
Clinical Research Associate
Pharm-Olam International
01.2008 - 10.2010
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Clinical Research Associate
United Therapeutics
08.2007 - 01.2008
Clinical Research Associate I/II
Thermo Fisher (Formerly PPD, Inc)
07.2005 - 08.2007
Clinical Research Coordinator
Cedars-Sinai Medical Center
06.2003 - 07.2005
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Education
Bachelor of Science - Nursing
Olivet Nazarene University
Bourbonnais, ILAssociate of Science - Nursing
Parkland College
Champaign, ILSkills
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
- Team leadership/Line management
- Portfolio management
- Project organization/strategy
- Vendor management
- Process improvement
- Budget management
- Risk/Issue identification and mitigation
- Operational time-line management
United States Army Veteran
United States Army Veteran -Combat Field Medic 1994-2002
Certification
Nursing License, License #231334, North Carolina
Timeline
Associate Director Clinical Trial Management
Syneos Health
06.2022 - Current
Director of Clinical Operations
Lightship, Inc
11.2021 - 04.2022
Associate Clinical Lead Director
IQVIA
06.2021 - 10.2021
Principal Clinical Trial Manager
Thermo Fisher (Formerly PPD, Inc)
06.2015 - 05.2021
Clinical Manager
Premier Research
09.2013 - 05.2015
Clinical Trial Manager
Novella Clinical
10.2012 - 09.2013
Clinical Trial Manager
PRA International
10.2010 - 10.2012
Clinical Research Associate
Pharm-Olam International
01.2008 - 10.2010
Clinical Research Associate
United Therapeutics
08.2007 - 01.2008
Clinical Research Associate I/II
Thermo Fisher (Formerly PPD, Inc)
07.2005 - 08.2007
Clinical Research Coordinator
Cedars-Sinai Medical Center
06.2003 - 07.2005
Bachelor of Science - Nursing
Olivet Nazarene University
Associate of Science - Nursing
Parkland College
Similar Profiles
JENNY CAROLINA CASTELLANOSJENNY CAROLINA CASTELLANOS
Senior CRA at Syneos HealthSenior CRA at Syneos Health
Korissa PayneKorissa Payne
Engagement Center Medical Information Support Spec at Syneos HealthEngagement Center Medical Information Support Spec at Syneos Health
Caroline WaksmunskiCaroline Waksmunski
Consultant at Syneos HealthConsultant at Syneos Health