Lindsay Mann
Greenwood,IN
Summary
Seasoned Associate Director of Research Systems offering over 20 years of clinical research experience in an academic health setting working with Cancer Centers, CTSAs, and research groups across the University and partner health systems. Adept at supporting clinical research applications and providing data, reports, and dashboards used for strategic operations to a variety of audiences. Experienced in system implementation and integrations, team development, and process improvement. Skilled in creating and designing tools for electronic data capture. Consistently utilizes resources and problem-solving skills combined with clinical research knowledge to promote organizational efficiency and promote progress.
Overview
23
23
years of professional experience
1
1
Certification
Work History
ASSOCIATE DIRECTOR OF RESEARCH SYSTEMS
Office of Clinical Research for Indiana (Indiana University)
01.2019 - Current
- Led team of 8 personnel, supervising daily performance as well as establishing performance goals for providing feedback on methods for reaching those milestones.
- Cultivated positive rapport to boost morale and promote employee retention.
- Assisted in evaluating potential acquisitions of new software for clinical research management based on compatibility with existing infrastructure and oversaw the implementation of new technology systems to modernize operations and increase overall efficiency.
- Collaborated with cross-functional teams to coordinate seamless integration between multiple applications used in clinical research to streamline business processes in support of academic and health system initiatives.
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Provided data, reports, and summaries using various reporting tools to provide stakeholders with actionable insights into research operations.
- Managed vendor relationships, negotiating contracts and ensuring timely delivery of support services.
- Developed and documented policies, procedures and standards used in managing clinical research applications and research operations.
- Maintained compliance with industry regulations, including 21 CFR Part 11, by conducting thorough audits of applications and associated processes.
- Establishes short-term business plans and long-term operational objectives to comply with university and health system goals.
- Acted as advisor to senior leadership and executive committees on research systems and applications used in clinical research management and operations including OnCore, EVAL, eRegulatory, eConsent, EDC, and Particpant Payments.
MANAGER OF RESEARCH SYSTEMS
Office of Clinical Research for Indiana (Indiana University)
03.2013 - Current
- Led teams of up to 8 personnel, establishing team priorities, maintaining schedules, and monitoring performance.
- Developed a team of highly effective individuals through effective recruitment, extensive onboarding program, and cross-training existing employees to maximize team agility and performance.
- Established strong relationships with key industry partners and vendors, creating mutually beneficial opportunities for growth and collaboration.
- Improved overall departmental efficiency by streamlining intake processes and implementing new collaboration tools utilizing REDCap.
- Led and collaborated with cross-functional teams to achieve system implementation goals, fostering collaboration and innovation.
- Served as a subject matter expert on clinical research applications, offering guidance to both technical staff and end-users alike.
- Diagnosed and resolved issues with research applications and processes and escalated problems with knowledgeable support and quality service.
- Implemented new research applications, features, and enhancements to existing applications.
- Oversaw software upgrades as well as the implementation of corresponding changes.
- Facilitated end-user adoption through comprehensive training sessions, eModules, and documentation development.
- Assisted senior leadership in managing multiple aspects of research operations by providing data for custom reports using various reporting tools to provide stakeholders with actionable insights into business operations.
CLINICAL RESEARCH APPLICATION MANAGER
IU Simon Cancer Center
01.2011 - 02.2013
- Defined and initiated projects in the Cancer Center clinical research management (CRMS) and electronic data capture (EDC) system, OnCore.
- Corresponded with various departments, therapeutic teams and staff roles to understand the various needs and processes.
- Assisted with development of new workflows to increase efficiency.
- Developed case report forms and user documentation for multiple therapeutic areas within oncology.
- Served as a subject matter expert for OnCore, offering training, guidance, and documentation to both technical staff and end-users alike.
- Review the internal policies and working systems and report about it to the management so they can improve upon them.
- Accommodated reporting needs for the Cancer Center and associated Clinical Research Office by creating reports and providing requested data.
- Optimized application functionality by coordinating upgrades, patches, installations, and migrations as needed.
- Collaborated with cross-functional teams to define requirements for new application features, driving successful project completion.
- Resolved issues and escalated problems with knowledgeable support and quality service.
INTERIM CLINICAL RESEARCH OFFICE MANAGER
IU Simon Cancer Center
03.2009 - 01.2011
- Provided oversight to a large team of clinical research professionals, while maintaining quality and compliance
- Assisted in the recruitment process, conducting interviews and onboarding new employees to promote a seamless integration into the team dynamic.
- Conducts a variety of personnel actions including hiring, promotion, performance management, and dismissal.
- Assisted in organizing and overseeing staff assignments to drive operational excellence.
- Handled sensitive information with discretion, maintaining confidentiality of company documents and personnel records.
- Developed and enforced office policies that aligned with company values and regulatory requirements, maintaining compliance.
- Collaborated with physicians, research coordinators and research nurses in multiple therapeutic areas to provide guidance on various clinical research processes.
- Coordinated internal efforts to facilitate needs of vendors, CROs, pharmaceutical sponsors and external research sites in an effective manner.
CLINICAL RESEARCH EDUCATION COORDINATOR/ONCORE APPLICATION ADMINISTRATOR
IU Simon Cancer Center
04.2007 - 03.2009
- Developed and conducted education and training programs for clinical research professionals dealing with clinical study activities and concepts.
- Developed and enforced research office policies, procedures, and standards within the Clinical Research Office and Cancer Center.
- Assisted clinical research staff with clinical study management tools and techniques as well as regulatory concerns.
- Observed work of clinical research staff to evaluate performance, and to recommend changes that could strengthen their skills.
- Interpreted and enforced both GCP and FDA regulations for Cancer Center staff.
- Managed the Clinical Research Management (CRMS) and Electronic Data Capture (EDC) system used by the Cancer Center including coordination of secure system access, configuration of customizable application settings, and managing upgrades, and serving as the subject matter expert offering guidance to promote efficiencies and reach organizational goals.
- Developed comprehensive training materials for end-users, promoting smooth adoption of a CRMS by both the Cancer Center and Clinical Research Office.
- Provided product support for the CRMS and escalated to the vendor for further discussion as required.
- Created including protocol calendars, case report forms, and financials calendars in the OnCore CRMS.
- Assisted Biostatisticians and Data Managers in review and analysis of data pulled from the Oncore database.
- Collaborated with cross-functional teams to develop innovative solutions that met business needs and objectives.
- Supported continuous improvement efforts through proactive identification of inefficiencies within internal workflows or processes.
CLINICAL RESEARCH SPECIALIST
IU Simon Cancer Center
04.2004 - 04.2007
SENIOR CLINICAL RESEARCH TECHNICIAN
IU Simon Cancer Center
06.2003 - 04.2004
QUALITY ASSURANCE SPECIALIST
Integrity Pharmaceuticals
04.2003 - 05.2003
QUALITY CONTROL CHEMIST
Integrity Pharmaceuticals
07.2002 - 10.2002
CLINICAL DIAGNOSTICS SERVICES (CDS) ASSOCIATE
Eli Lilly
04.2001 - 11.2001
Education
B.A. in Biology -
HANOVER COLLEGE
Hanover, INContinuing Education -
IUPUC
Columbus, INClinical Research Certification, Project Management -
IUPUI
Indianapolis, INSkills
- Project Management
- Strategic leadership
- Analytical Thinking
- Coaching and Mentoring
- Report Generation
- Team Collaboration and Leadership
- Technical implementation
- Critical Thinking
- Onboarding and training
- Product Management
- Data Collection
- Performance Tracking and Evaluation
Research Applications
- Proficient in use and understanding of OnCore and Advarra suite of products including Payments, eReg, EDC, eConsent, and EVAL.
- Proficient user of REDCap
Accomplishments
- Self-motivated, with a strong sense of personal responsibility.
- Learned and adapted quickly to new technology and software applications.
- Knowledgeable in clinical research operations and regulations.
- Experienced in implementation and introduction clinical research systems used in both the Cancer Center and across the research enterprise.
- Experienced in implementing training programs and providing support for clinical research professionals as well as for clinical research systems.
- Collaborated on and led integration projects associated with both the clinical research management system, EHR, and IRB system.
Certification
- SOCRA Certification, Certified Clinical Research Professional
- IUPUI, Fundamentals of Supervision Certification
- Advarra, Certified Oncore Trainer
Timeline
ASSOCIATE DIRECTOR OF RESEARCH SYSTEMS
Office of Clinical Research for Indiana (Indiana University)
01.2019 - Current
MANAGER OF RESEARCH SYSTEMS
Office of Clinical Research for Indiana (Indiana University)
03.2013 - Current
CLINICAL RESEARCH APPLICATION MANAGER
IU Simon Cancer Center
01.2011 - 02.2013
INTERIM CLINICAL RESEARCH OFFICE MANAGER
IU Simon Cancer Center
03.2009 - 01.2011
CLINICAL RESEARCH EDUCATION COORDINATOR/ONCORE APPLICATION ADMINISTRATOR
IU Simon Cancer Center
04.2007 - 03.2009
CLINICAL RESEARCH SPECIALIST
IU Simon Cancer Center
04.2004 - 04.2007
SENIOR CLINICAL RESEARCH TECHNICIAN
IU Simon Cancer Center
06.2003 - 04.2004
QUALITY ASSURANCE SPECIALIST
Integrity Pharmaceuticals
04.2003 - 05.2003
QUALITY CONTROL CHEMIST
Integrity Pharmaceuticals
07.2002 - 10.2002
CLINICAL DIAGNOSTICS SERVICES (CDS) ASSOCIATE
Eli Lilly
04.2001 - 11.2001
B.A. in Biology -
HANOVER COLLEGE
Continuing Education -
IUPUC
Clinical Research Certification, Project Management -
IUPUI
- SOCRA Certification, Certified Clinical Research Professional
- IUPUI, Fundamentals of Supervision Certification
- Advarra, Certified Oncore Trainer
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