Mina Dowd
Fuquay Varina
Summary
Over 26 plus years’ experience focused in Study Start-Up. I have held a variety of positions from Sr. SSU Specialist up to Associate Director of Startup. I have experiences with the US/CAN, global study start up and regulatory authorities submissions. I also have experience in business development at it relates to BDs, RFPs, I pride myself as being a mentor, training and advocate for SSU. My therapeutic experiences are in Oncology, Neurology, Infectious Disease and Rare Disease.
Overview
27
27
years of professional experience
Work History
Sr. Clinical Trial Manager
Syndax Pharmaceuticals
Boston
10.2022 - 05.2025
- Served as a liaison between sponsors, CROs, investigators, regulatory agencies when necessary.
- Prepared training materials for investigators prior to initiating a study.
- Provided direction to external vendors such as CROs regarding protocol development, case report forms design, data management systems.
- Reviewed patient data from various sources to identify trends or other important information related to the trial.
- Organized and managed clinical trials in compliance with ICH-GCP guidelines.
- Created detailed timelines for each project to ensure milestones were met on schedule.
- Performed regular audits of sites participating in clinical trials to ensure adherence to GCP and ICH guidelines.
- Monitored progress of clinical trials, identified problems and developed solutions to ensure timely completion of studies.
- Presented updates about ongoing studies at internal team meetings and other relevant forums.
- Participated in meetings with sponsors, CROs, investigators, regulatory agencies concerning ongoing projects.
- Managed budgeting process including tracking actuals against budgeted costs for each trial.
- Assisted with preparation of investigator brochures and informed consent forms as needed.
- Ensured that appropriate safety reporting procedures were followed during the course of a study according to FDA regulations.
- Reviewed study documents for accuracy, completeness and regulatory compliance.
- Evaluated potential new sites for participation in clinical trials based on their qualifications.
- Maintained accurate records of all actions taken throughout the course of each study.
- Developed and implemented clinical trial management plans, protocols and reports.
- Coordinated activities between internal staff members, vendors and third party contractors involved in the execution of clinical trials.
- Kept patient care protocols and clinical trial operations in compliance.
- Monitored subject enrollment and tracked dropout details.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Associate Director of Study Start-Up Consultant with Athersys
MLD Clinical Services
Fuquay Varina
03.2022 - 08.2022
- Serve as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects
- Prepared and submitted Central and Local EC/IRB/RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Creates and reviews inform consent forms
- Oversite and management of startup plans and templates development
- Proactively forecast submission/approval timelines and ensured they were adhered to. If forecasted timelines were not met, provided clear rationale for delays, provided contingency plan to mitigate impact, and escalate issue(s) immediately
- Vendor management (i.e. selection of vendors, management, review of SOW and invoice management.
- Drives site identification, site selection, and site activation process
- Review and approve monitoring visit reports
Senior Site Activation Manager
Catalyst Clinical Research
11.2021 - 03.2022
- Partner with Study Optimization to leverage site intelligence to inform the Start Up Project Plan
- Monitor project schedule and scope to ensure both remain on track; implement and follow pre-approved procedures for any deviations
- Proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems
- Create or review required project start-up plans. Distribute, implement and monitor compliance to project plans and revise as necessary. Review Client vs CRO responsibilities related to start-up
- Prepared and actively participate as operational lead in internal Project Review meetings
- Meet financial performance targets for assigned project(s)
Global Start-Up Project Manager on assignment with Pfizer
Eliassen Group
Princeton
06.2021 - 11.2021
- Partner with Study Optimization to leverage site intelligence to inform the Start Up Project Plan
- Monitor project schedule and scope to ensure both remain on track; implement and follow pre-approved procedures for any deviations
- Proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems
- Create or review required project start-up plans. Distribute, implement and monitor compliance to project plans and revise as necessary. Review Client vs CRO responsibilities related to start-up
- Prepared and actively participate as operational lead in internal Project Review meetings
- Meet financial performance targets for assigned project(s)
Start-Up Project Manager
Covance Clinical Development Services
Princeton
11.2019 - 06.2021
- Proactively manage site activation and maintenance progress, expectations and deliverables to a Lead SUPM or the Project Lead/client, as applicable
- Proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems
- Create or review required project start-up plans. Distribute, implement and monitor compliance to project plans and revise as necessary. Review Client vs CRO responsibilities related to start-up
Senior Site Start Up Associate
Premier Research
RTP
03.2019 - 11.2019
- Serve as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects
- Prepared and submitted Central and Local EC/IRB/RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Proactively forecast submission/approval timelines and ensured they were adhered to. If forecasted timelines were not met, provided clear rationale for delays, provided contingency plan to mitigate impact, and escalate issue(s) immediately
Associate Project Manager/CTM
ICON/DOCs
RTP
03.2018 - 03.2019
- Contributing to the preparation of Training Materials (Investigator Meetings, Site Evaluation and Initiation Training)
- Managing the process for planning and procuring ancillary clinical supplies.
- Facilitating authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list
Manager of Regulatory Compliance
Worldwide Clinical Trials
Morrisville
12.2013 - 05.2017
- Collaborated with Business Development and other functional teams to strategize for sponsor RFPs and BD meetings
- Provided oversight on North America studies (up to 50 trials).
- Provided instruction to sponsor/CRO personnel on policies and procedures as related to central site regulatory documentation collection and maintenance.
- Attended senior level and governance calls to provide updates to sponsor/CRO representative
QA Associate Documents & Records
Talecris
RTP
05.2011 - 08.2011
- Established and maintained Quality documentation for (e.g. Procedures and Specifications) according to Corporate, regional and division procedures, Regulatory requirements such as those outlined by EU and FDA as well as guidance outlined by the International Conference on Harmonization
- Evaluated the accuracy of SOPs and company records to ensuring accurate and timely archival and retrieval of records within the R&D Records management systems (Records include but are not limited to Clinical Study/Trial files, Pre-Clinical reports and notebooks, data files, contracted study files and periodic review/update records such as Investigator Brochures and Key Opinion Leader contact records)
- Administered Training matrices in the R&D departments while ensuring these were up to date and meet company and departmental requirements through reporting to management and interactions with Performance Development
Clinical Trials Assistant II
Duke Clinical Research Institute
Durham
05.2010 - 05.2011
- Prepared and disseminated status reports on regulatory documents, patient enrollment, and data activities for assigned sites
- Supported clinical operations team through communication with sites, collection and entry of current site status into systems prior to site visits and meetings, regular updates to teammates and trial supervisors, and other project activities
- Assisted with investigator meeting preparation by mailing invitations, tracking responses and travel arrangements and assembly of meeting materials. Provided clerical and administrative support in-person at meeting
Site Start Up Associate II
Duke Clinical Research Institute
Durham
06.2008 - 05.2010
- Performed site start-up activities for multiple sites and possibly multiple projects, according to the study-specific plan for collecting essential study documents. Assess sites’ regulatory compliance, including but not limited to informed consent review and review of investigative regulatory files
- Maintain essential study and site communication records, electronic and hard copy, removing non-essential communication to meet study and organizational and government standards, as directed
- Utilize DCRI tools and study documents, recommend revisions to improve efficiencies of tools, study documents, and study processes; independently develop study-specific versions, as directed
Site Start Up Associate II
PAREXEL
Durham
04.2006 - 04.2007
- Performed and coordinated rapid study start-up activities associated with clinical trials
- Developed collaborative relationships with CRAs, investigator sites and sponsor company personnel
- Develop, create, review, and negotiate department contracts/budgets for Investigational Sites (Approximately 200+ sites across four protocols)
Site Start Up Associate II
GlaxoSmithKline
Durham
07.2004 - 04.2006
- Collection of regulatory, legal and financial documentation in accordance with FDA, GCP, ICH, and SOP guidelines
- Develop, create and review department contracts for Investigational Sites (Approximately 75+ sites across three protocols)
- Follow project-specific plans for startup activities, including distributing, and collecting essential study document packages and negotiating site contracts and site budgets, finalizing contracts for signature, tracking contracts within CTMS database, and generating contract status reports
Site Start Up Associate II
Quintiles
RTP
07.1998 - 04.2003
- Assisted project management, investigator, supervisor and CRAs with most aspects of recruitment of clinical studies for Oncology, HIV, Diabetes, and Cardiovascular
- Acted as liaison between Quintiles, study sites and sponsors
- Collected subject information as it pertains to enrollment into selected clinical studies
Education
Bachelor of Science - Health Administration
University of Phoenix
Phoenix, AZ12-2026
Skills
- Management of SSU and Feasibility teams
- Project management
- Clinical trial management
- Regulatory compliance
- Risk assessment
- Team collaboration
- Partnership development
- Corporate governance
Therapeutic Experience
- Infectious Disease: HIV Phase II and III
- Oncology: Acute Myeloid Leukemia, Breast Cancer, Non-Small Cell Lung Cancer Phase II/III
- Neurology: Alzheimer’s Phase II and III
- Cardiovascular: Congestive Heart Failure Phase III
Timeline
Sr. Clinical Trial Manager
Syndax Pharmaceuticals
10.2022 - 05.2025
Associate Director of Study Start-Up Consultant with Athersys
MLD Clinical Services
03.2022 - 08.2022
Senior Site Activation Manager
Catalyst Clinical Research
11.2021 - 03.2022
Global Start-Up Project Manager on assignment with Pfizer
Eliassen Group
06.2021 - 11.2021
Start-Up Project Manager
Covance Clinical Development Services
11.2019 - 06.2021
Senior Site Start Up Associate
Premier Research
03.2019 - 11.2019
Associate Project Manager/CTM
ICON/DOCs
03.2018 - 03.2019
Manager of Regulatory Compliance
Worldwide Clinical Trials
12.2013 - 05.2017
QA Associate Documents & Records
Talecris
05.2011 - 08.2011
Clinical Trials Assistant II
Duke Clinical Research Institute
05.2010 - 05.2011
Site Start Up Associate II
Duke Clinical Research Institute
06.2008 - 05.2010
Site Start Up Associate II
PAREXEL
04.2006 - 04.2007
Site Start Up Associate II
GlaxoSmithKline
07.2004 - 04.2006
Site Start Up Associate II
Quintiles
07.1998 - 04.2003
Bachelor of Science - Health Administration
University of Phoenix