Jacob Franey
Olathe,KS
Summary
Experienced and high performing Sr. Global Clinical Trial Manager with 8 years of industry experience in clinical research. Experienced in phase I-IV trials (Oncology and C> focused). Vast knowledge of regulatory compliance and ICH GCP. Well versed in effective communication with investigators, site staff, and upper management. Experienced with management of budgets, vendors, and utilizes leadership qualities to promote effective task completion. Candidate for Doctorate Degree in Clinical Research and Regulatory Managment.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Senior Global Clinical Operations Leader- Biotech
Parexel International
08.2023 - Current
- Managed Global Phase I, II, and III Clinical Research Trials in Oncology and Cell and Gene Therapy
- Managed a Team of 15 Global CRAs
- Increased team productivity by streamlining communication and implementing effective project management strategies.
- Led cross-functional teams to achieve company-wide goals, fostering a culture of collaboration and innovation.
- Spearheaded process improvements, leading to enhanced efficiency and cost savings across various departments.
- Mentored junior staff members, helping them develop leadership skills and advance their careers within the organization.
- Cultivated strong relationships with stakeholders, improving overall satisfaction and trust in leadership capabilities.
- Directed high-impact projects from conception to completion, consistently delivering on time and within budget constraints.
Clinical Trial Manager
IQVIA Biotech
04.2022 - 08.2023
- Coordinated global clinical trials focused on Oncology from startup to close out (Phases I-IV)
- Maintained study budgets including forecasting, change in scope, and development
- Conducted/Presented protocol and job-specific training with CRAs and other CRO staff
- Responsible for management of CRAs' study deliverables and daily duties
- Liaised with sponsors and external vendors to promote teamwork and efficiency
- Acted as a point of escalation for clinical operations issues
- Provided project oversight for all aspects of the clinical trial process from startup to closeout
- Created and maintained metrics reporting tools for all studies
- Attended Bid Defense meetings on behalf of clinical operations
- Acted as a CTM Mentor in the IQB Mentoring/Buddy Program
- Global CTM for studies in the following countries: USA, France, Spain, Germany, Italy, Netherlands, Greece, and Canada
Senior Clinical Research Associate
IQVIA Biotech
05.2021 - 04.2022
- Monitored global early phase oncology clinical trials from start up to close out
- Successfully managed 4 protocols and 25+ sites
- Completed lead CRA activities and liaised directly with sponsor contacts and management
- Mentored and trained new hire CRAs
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Took on Clinical Trial Manager tasks
Clinical Research Associate 2
ICON Clinical Research
06.2020 - 05.2021
- The lead FSP Sanofi USOR CRA for a NSCLC study.
- Monitored clinical trial activities in compliance with FDA regulation, ICH/GCP guidelines, and company SOPs, to support New Drug Applications.
- Supported project teams in placement, implementation, communication, site management, recruitment and retention issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects.
- Supported studies in Oncology, Neurology, and Pulmonary therapeutic areas.
Clinical Research Associate
IQVIA
11.2018 - 06.2020
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication.
- Managed a full site load of 12+ sites and 3+ protocols while being 100% compliant in metrics
Clinical Trials Assistant (Early Clinical Talent)
IQVIA
07.2017 - 11.2018
- Maintained Trial Master File for multiple studies.
- Liaised with multiple levels of management to ensure quality of study systems
- Developed understanding of different therapeutic areas such as dermatology, hyperlipidemia, and oncology.
- Utilized leadership qualities by mentoring newly hired CTAs
- Developed team communications and information for internal meetings.
Education
DPP - Clinical Research And Regulatory Managment
Arizona State University
Tempe, AZ12-2026
Master of Science - Clinical Research Management
Arizona State University
Tempe, AZ12.2022
Bachelor of Science - Biology
Benedictine College
Atchison, KS05.2017
Skills
- Budget Maintenance
- Coordinating site operations
- Protocol adherence
- Project Management
- Effective Communication
- Leadership
- Vendor Management
- Mentoring
- Metrics and Reporting
- Quality Management
- Escalation
- Bid Defense
Affiliations
Association of Clinical Research Professionals (ACRP) Member
Certification
- ICH GCP Expert Certified
- Certified Clinical Research Associate (CCRA), ACRP - August 2019-November 2022
Additional Information
- College athlete from 2013 to 2017.
- Served as a member of the IQVIA Biotech Executive Leadership Team Shadow Board for 2022 (Represented >4,000 employees)
- Presented on multiple town hall and all staff meetings to 500+ employees
Timeline
Senior Global Clinical Operations Leader- Biotech
Parexel International
08.2023 - Current
Clinical Trial Manager
IQVIA Biotech
04.2022 - 08.2023
Senior Clinical Research Associate
IQVIA Biotech
05.2021 - 04.2022
Clinical Research Associate 2
ICON Clinical Research
06.2020 - 05.2021
Clinical Research Associate
IQVIA
11.2018 - 06.2020
Clinical Trials Assistant (Early Clinical Talent)
IQVIA
07.2017 - 11.2018
DPP - Clinical Research And Regulatory Managment
Arizona State University
Master of Science - Clinical Research Management
Arizona State University
Bachelor of Science - Biology
Benedictine College
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