Allison Owen
Austin,TX
Summary
Motivated and customer-focused, Allison is an experienced Start-Up Team Manager in Project Delivery with 18 years of expertise in clinical research. With a strong background in managing the start-up of clinical trials, she has successfully implemented study protocols, overseen project management, conducted feasibility assessments, selected sites, activated sites, enrolled patients, and ensured compliance with regulatory and local country authorities. Allison has a bachelor's degree in Communication Sciences and Disorders from Baylor University.
Overview
19
19
years of professional experience
Work History
Start-up Team Manager
PPD/Thermo Fisher Scientific
05.2022 - Current
- Leads, executes and achieves site activation and amendment deliverables within a region or globally, within the assigned projects, by managing the scope of work to timelines, costs and quality
- Ensures all project deliverables meet contracted and customer's expectations, providing accurate projections, reports and updates, as well as ongoing risk assessments
- Develops and maintains strategic relationships with customers in alignment with assigned projects, ensuring individual project targets are met and services are provided with the highest quality standards
- Manages the contract and regulatory site facing study personnel to ensure activation timelines are met
- Serves as the primary startup contact for the Project Lead and client
Project Delivery Lead
Syneos Health
11.2020 - 05.2022
- Responsible for overseeing all Start-Up activities from site selection/recommendation through site activation ready
- Develops integrated SSU timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor
Project Manager
Syneos Health
10.2019 - 11.2020
- Supports overall project management of clinical studies by helping control the scope, schedule and cost of assigned project(s), which include liaising with Customers, vendors and/or investigative sites to manage projects from proposal development to final deliverables to the customer
Sr. Project Specialist
Syneos Health (prev. INC Research)
09.2014 - 10.2019
- Supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers' requirements
- Responsibilities include project administration, reporting, communication between vendors, internal and sponsor teams
Project Associate
Premier Research
10.2013 - 09.2014
- Developed and maintained project specific plans, customized project templates and tracked project documents
- Coordinated and tracked project-related information, status reports and communication across the project team and departments
- Maintained the study electronic Trial Master File and coordinated collection of regulatory documents from other functional groups
Regulatory Specialist
Hospital Physicians in Clinical Research (HPCR)
08.2010 - 05.2013
- Managed the Regulatory department for over 20 industries sponsored and investigator-initiated studies
- Managed IRB Submissions and study continuing reviews
- Managed the entire study start-up process consisting of detailed study specific submission reports, regulatory documents and informed consent writing
Subject Recruiter
Cedra Clinical Research
04.2010 - 08.2010
- Recruited potential subjects into healthy and patient studies phase I, II studies
- Performed audits to ensure the subjects meet the inclusion/ exclusion criteria for the specific study they have been signed up for by the recruiters
Trainee Clinical Research Associate
Chiltern
04.2009 - 03.2010
- Maintained the Trial Master Files
- Audited study files to ensure FDA compliance
- Attended all study meetings and took minutes to distribute to study staff
- Attended monitoring visits with clinical research associates
Clinical Trials Assistant
Zimmer Spine (formerly Abbott Spine)
08.2006 - 03.2009
- Key contributor to study start-up and continuation of IDE clinical trials
- Created a study document filing system and maintained study and regulatory documentation
- Ensured timely renewal of IRB approvals and other investigator documents
- Served as point of contact to CRO, IRB and site personnel
Education
B.A. - Communication Sciences and Disorders
Baylor University
Waco, TX05.2006
Skills
- Microsoft Office Suite
- Oracle Activate
- Veeva Vault
- ETMF
- CTMS
- Adobe Acrobat
- IMedidata RAVE
- Clarity
Computer Experience
- Microsoft Office Suite
- Oracle Activate
- Veeva Vault
- ETMF
- CTMS
- Adobe Acrobat
- IMedidata RAVE
- Clarity
Timeline
Start-up Team Manager
PPD/Thermo Fisher Scientific
05.2022 - Current
Project Delivery Lead
Syneos Health
11.2020 - 05.2022
Project Manager
Syneos Health
10.2019 - 11.2020
Sr. Project Specialist
Syneos Health (prev. INC Research)
09.2014 - 10.2019
Project Associate
Premier Research
10.2013 - 09.2014
Regulatory Specialist
Hospital Physicians in Clinical Research (HPCR)
08.2010 - 05.2013
Subject Recruiter
Cedra Clinical Research
04.2010 - 08.2010
Trainee Clinical Research Associate
Chiltern
04.2009 - 03.2010
Clinical Trials Assistant
Zimmer Spine (formerly Abbott Spine)
08.2006 - 03.2009
B.A. - Communication Sciences and Disorders
Baylor University
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