Ginger Autry Email & Phone Number

United States

Menlo Park, California

• Effectively managed Medical Information Requests (MIR) process by training and supporting a call center,creating 25 customized response letters, and ensuring compliance with all applicable procedures.
• Contributed to creation, training, and implementation of 12 Medical Affairs policies and procedures, and 12materials for scientific exchange.
• Expertly guided, mentored, and trained external scientific speakers and key opinion leaders on content formedical and promotional events.
• Ensured accuracy, completion, and integrity of scientific data used in over 500 advertising and promotionalmaterials.
• Developed educational materials for 4 approved drug/device combination products (3 PMA, 1 NDA) inconjunction with marketing team to assist with field sales training.
• Saved $100K annually on consultant costs by training full-time staff on pharmacovigilance reporting.

• Successfully managed 300-patient pivotal clinical trial at 35 sites across the U.S. Completed enrollment 6-months early allowing reimbursement submission 1-year ahead of schedule.
• Organized investigator and research coordinator meetings resulting in high engagement and increasedpatient enrollment by 30%. Managed field team of 12 CRAs by selecting, developing, training, and coaching resulting in.
• Developed manuals, procedures, monitoring reports, guidelines, and an onboarding and mentorshipprogram to ensure standardization and consistency across field team.
• Conducted regular safety committee reviews for adverse events, device deficiencies, and protocol deviation.

Senior CRA for multiple sites regarding Transcatheter Aortic Valve Replacement (TAVR) clinical trials.

• Trained, mentored, and educated new CRA hires, as well as investigators and study coordinators regarding protocols, therapies, medical devices, regulations, and GCPs.
• Successfully managed 10 clinical trial sites and 5 cardiology device study protocols resulting in no FDA audit findings.

• Effectively managed Canada and Latin America regions for a 3000-patient global trial. Controlled coststhrough strategic negotiation of vendor and site budgets.
• Boosted global importation of devices to Latin America in alignment with regulations through successful process creation and management of Canada and Latin America regions.
• Organized investigator meetings and trainings.

Santa Clara, CA

Successfully managed multiple cardiology device clinical trial sites and study protocols

Established highly informative process and procedure manual for clinical team for use in training new hires.Conducted site qualification/initiation, interim monitoring, and close-out visits for multiple studies atinvestigational sites.

United States

• Spearheaded overall development of research team for dynamic cardiology physician practice by building, managing, developing, and overseeing 3 CRCs and 2 Regulatory Administrators and over 50 pharmaceutical and device.
• Utilized solid organization, prioritization, multi-tasking, and time management skills to manage departmentbudget, study budgets, and execution of study protocols effectively and efficiently.

Tupelo, MS

• Cath Lab RN (05/1998 – 01/2001)
• Assisted cardiologist with procedures such as cardiac cath, percutaneous cardiovascular intervention, andpacemaker/ICD implant procedures. Administered medications and monitored vital signs and patient statusduring.
• Responsible for care and transport of the critically ill or injured adult and pediatric patients at a Level Itrauma center.

Columbus, MS

Responsible for care of the critically ill or injured adult and pediatric patients in multiple therapeutic areas.

Bachelor Of Science (Bs), Registered Nursing/Registered Nurse

RN-BSN Degree

High School Diploma