Lindsay Kline Email and Phone Number

I'm responsible for defining implementation methodology and best practices globally for the Veeva Site Connect application and partnering with Product Management to drive implementation excellence.

I was part of the Vault Clinical Operations team involved in leading and supporting implementations of Veeva's Clinical Operations applications. From Sep 2022 to Jun 2023, I also acted as the Global Domain Lead for Connected Studies responsible for:• Overseeing and supporting the methodology & tools that enable the field to implement and deliver in our domain• Providing leadership and oversight to application-specific SMEs• Communicating methodology changes and updates to the field• Partnering with cross-teams on cross-application dependencies and challenges

Promoted from Quality Assurance Coordinator after demonstrating leadership ability and exceeding performance expectations. Served as protocol and data capture expert for Clinical Operations and Quality Assurance teams, critically thinking and providing logical and rapid problem solving skills to time-sensitive issues. Provided support, supervision, and training to Quality Assurance team in preparation for site monitoring visits and FDA and sponsor audits. Ensured source document compliance with protocol requirements and GCP guidelines. Assisted Quality Assurance Manager with HR administrative tasks and personnel oversight. Implemented and maintained performance metrics for departments.Key Accomplishments• Successfully prepared for career total of 7 FDA audits and 11 sponsor audits by reviewing critical protocol and safety datapoints and compiling report of findings with recommended solutions• Redesigned subject medical history intake documents, physician’s evaluation forms, and source document templates used in all subject charts site-wide to improve data captured• Collaborated in committee to evaluate eSource platforms and compare with internal site workflow for future site implementation• Led committee for management of site-wide daily morning meeting which revamped meeting format, content, and technology• Managed completion of Quality Assurance study start-up tasks, including liaising between business development and source document contractor• Created and reviewed internal training SOPs and trained site staff as required

Promoted from Clinical Research Assistant after indicating interest in data monitoring and quality department goals. Acted as protocol expert and internal monitor for 15-20 assigned studies and up to 80 active subjects at a time. Reviewed study participant research data to ensure compliance with study protocols, GCP guidelines, and site guidelines from study start-up to close-out. Ensured audit and inspection readiness throughout study duration. Verified safety of subjects during trial through review of AEs/SAEs and site adherence to GCP guidelines and FDA regulations. Confirmed appropriate resolution and documentation of errors and incomplete data in subject binders by working closely with the Principal Investigator and other department leads. Examined and cataloged informed consent documents for all site studies.Key Accomplishments• Independently prepared for site monitoring visits, FDA audits, and sponsor audits of assigned studies with minimal to no findings• Identified staff performance deficiencies and assisted in developing training programs for research staff based on review of data• Trained research staff on completion of informed consent documents and proper documentation of study data• Acted as site subject matter expert on informed consent documents

Provided direct support to research coordinators in completion of protocol-specific study goals for 10-15 assigned studies. Created and maintained subject binders while ensuring accuracy of source documents and assessments. Filed lab results, ECG tracings and reports, and other relevant study documents in subject charts. Entered participant data and resolved queries in eCRF/EDC systems. Conducted inpatient and outpatient study visits, including collection of vital signs, performing urine drug screens, and facilitating completion of protocol-required assessments. Prepared and maintained laboratory kits and kit inventory for all assigned studies. Interacted with study sponsors and monitors during site initiation visits and study monitoring visits.

• Designed, conducted, and wrote honors thesis study on sex differences in facial expression recognition in adults• Programmed computer-based tasks, prepared data for analysis, and analyzed data• Examined the development of face perception in infants, worked in Photoshop to create various visual stimuli for developmental studies, recruited infant and adult participants, coded infants’ looking behaviors, and organized participant database