Edith Eastman
Decatur
Summary
Senior Clinical Trial Manager leveraging comprehensive experience in clinical monitoring and regulatory compliance to drive study success. Skilled in fostering collaboration among cross-functional teams and ensuring adherence to project timelines, resulting in improved patient recruitment and operational excellence throughout the clinical trial lifecycle.
Overview
24
24
years of professional experience
Work History
Sr Clinical Trial Manager
Syneos Health
Georgia
12.2022 - Current
- Managed site operations, clinical monitoring, and central monitoring deliverables, prioritizing patient safety and regulatory compliance.
- Managed site interactions from activation to closeout, enhancing patient recruitment and ensuring timely processing of investigator payments.
- Ensured quality of clinical monitoring, central monitoring, and site management deliverables while maintaining visibility of progress through approved tracking systems.
- Escalates to the global project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
- Employed strategic thinking and problem-solving to identify and implement effective risk mitigations.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Functioned as the escalation contact for investigator site staff communications and engaged with principal investigators and other site staff, including accompanying CRA team members to sites.
- Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
- Created and updated clinical study tools and templates.
- Ensures compliance with applicable IRB submission requirements and timelines on both sponsor and site level.
Clinical Trial Manager II
Syneos Health
Georgia
09.2021 - 12.2022
- Ensures quality of the clinical monitoring and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools.
- Collaborated with clients and functional departments to align clinical monitoring and site management activities with project deliverables.
- Ensures alignment of clinical activities to budget, including identification of out of scope activities and deliverables.
- Facilitated training sessions for the study team on protocol details, Case Report Form (CRF) completion, and study timelines.
- Led regular clinical study team calls to update status, facilitate ongoing training, and ensure accountability for deliverables.
- Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRD enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visit/calls, duration, and frequency) according to plan, and to oversee site and study team conduct and identify any risks to deliver or quality.
- Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct.
- Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan.
- Adheres to scope to ensure assigned clinical staff routinely assess site processes, perform review of all Source Documents and medical records, and perform Source Document Verification (SDV) per the CMP/SMP.
- Coordinated with data management functional lead to align planning for data cut and lock deadlines.
- Collaborates with other functions to ensure site compliance and delivery according to protocol, ICH/GCP and Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA).
Clinical Operations Lead
Syneos Health
Georgia
07.2020 - 09.2021
- Ensures quality of the clinical monitoring and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools.
- Reviewed Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), and enrollment data to oversee site and study team conduct, ensuring timely operational entry and identifying potential risks to quality and delivery.
- Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.
- Collaborated with cross-functional teams to ensure site compliance and adherence to protocol, ICH/GCP, GPP, and country regulations, including medical monitoring, safety, and quality assurance.
- Led regular clinical study team calls to provide status updates, deliver ongoing training, and ensure accountability for project deliverables.
- Facilitated training sessions for the study team on protocol details, CRF completion, and clinical guidelines to ensure compliance with study requirements.
- Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct.
- Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan.
- Proactively collaborates with the data management functional lead to plan towards data cut and lock deadlines.
- Maintained inspection readiness for clinical activities by regularly reviewing documentation and compliance.
Senior Clinical Research Associate II
Syneos Health
Georgia
08.2015 - 07.2020
- Performed site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Evaluated site and site staff performance, provided actionable recommendations for improvement, communicated serious issues to project team, and developed targeted action plans.
- Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Ensured documentation of the informed consent process met all regulatory standards for each subject/patient.
- Demonstrated diligence in protecting the confidentiality of each subject/patient.
- Assessed factors impacting subject/patient safety and clinical data integrity, including protocol deviations and pharmacovigilance issues, to ensure compliance and safeguard study integrity.
- Executed tasks outlined in clinical monitoring and site management plan to maintain regulatory standards.
- Evaluated site processes to ensure adherence to protocols and standards.
- Conducted Source Document Review of appropriate site source documents and medical records.
- Verified required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
- Applied query resolution techniques remotely and on site, and provided guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Utilized available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verified site compliance with electronic data capture requirements.
- Performed investigational product (IP) inventory, reconciliation and reviews storage and security.
- Applied knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Routinely reviewed the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Reconciled contents of the ISF with the Trial Master File (TMF).
- Ensured the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Implemented strategies to enhance subject/patient recruitment, retention, and awareness, contributing to overall study success.
- Entered data into tracking systems as required to track all observations, ongoing status and action items to resolution.
- Understood project scope, budgets, and timelines for own and others activities in the clinical team; managed site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Was able to quickly adapt to changing priorities to achieve goals / targets.
- Acted as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Ensured all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepared for and attended Investigator Meetings and/or sponsor face to face meetings.
- Participated in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attended clinical training sessions according to the project specific requirements.
- Provided guidance at the site and project level towards audit readiness standards and supported preparation for audit and required follow-up actions.
- Provided training and/or mentorship to more junior level CRAs.
Clinical Research Associate II
inVentiv Health
Decatur
05.2010 - 05.2013
- Managed clinical sites to ensure patient safety, adherence to regulations and data integrity. Responsibilities included:
- Conducted monitoring visits to ensure protocol adherence, qualification of study personnel and scientific validity of data generated.
- Ensured investigator obligations were met and compliant with applicable FDA and ICH guidelines.
- Verified data in CRF are in agreement with source documents, initiated data query resolution and confirmed resolution in a timely manner.
- Reconciled investigational site files to ensure compliance with ICH guidelines, project SOPs, and sponsor requirements.
- Identified site issues and initiated corrective action plans based on monitoring reports to enhance site performance.
- Facilitated investigator reviews and promptly reported adverse events to sponsor and IRB, ensuring regulatory compliance.
- Guided study site personnel to ensure consistency across sites, including assisting with the resolution of site issues and facilitating project timelines.
- Maintained compliance with drug storage regulations to safeguard medication integrity and availability.
Clinical Research Associate I
InVentiv Health
Decatur
02.2008 - 04.2010
- Managed clinical sites to uphold patient safety, ensure regulatory compliance, and maintain data integrity.
- Guided study site personnel to achieve consistency across sites, resolving site issues and facilitating adherence to project timelines.
- Reviewed case report forms (CRFs) to verify protocol adherence and support scientific validity.
Clinical Research Associate I
Premier Research Group
San Diego
01.2007 - 02.2008
- Managed clinical sites to uphold patient safety, comply with regulations, and maintain data integrity.
- Reviewed case report forms (CRFs) to confirm protocol adherence and reinforce scientific validity.
- Guided study site personnel to drive consistency across sites, resolving site issues and facilitating project timelines.
Senior Clinical Research Assistant
Premier Research Group
San Diego
08.2005 - 12.2006
- Managed selected clinical sites to ensure patient safety, adherence to regulations and data integrity.
- Supported core team in investigator recruitment, study start-up, and patient enrollment to ensure smooth project execution.
- Served as primary liaison among CRAs, sites, project managers, sponsors, and team members to facilitate communication and collaboration.
- Demonstrated a working knowledge of safety and efficacy issues, relevant FDA regulations and company policies.
- Collected and organized study-specific information to support timely project updates.
Clinical Trial Assistant
GlaxoSmithKline
Munich
11.2002 - 01.2005
- Coordinated investigator meetings and facilitated grant requests/payments to support project timelines.
- Acted as liaison between project leader, CRAs, and sites to enhance communication and project alignment.
- Established and managed project files and databases to ensure accurate tracking of project milestones.
- Worked within German/European regulatory framework and ICH/GCP standards.
Education
Bachelor - Cell Biology
Ludwig Maximilian Universitaet Muenchen
01-2002
Skills
- Trial management
- Risk Based Monitoring
- Regulatory compliance
- Site monitoring
- IRB submissions
- Source document verification
- Data management
- Rave EDC
- IWRS
- Team collaboration
Personal Information
Title: Sr Clinical Trial Manager
Languages
- German (native)
- English
Therapeutic Experience
- Cardiovascular, Hypertension, Generalized CVD
- Dermatology, Eczema/Dermatitis, Atopic Dermatitis
- Dermatology, Psoriasis, Plaque psoriasis
- Endocrinology/Metabolism, Diabetes treatment, Type 2 Diabetes Mellitus
- Gastroenterology, Inflammatory bowel disease (IBD), Ulcerative colitis
- Hematology, Thrombo-embolic disorders, Venous Thromboembolism
- Infectious Disease, Respiratory infections, Pneumococcal infection prophylaxis
- Infectious Disease, Viral infections, Chronic Hepatitis C
- Neurology, Autoimmune disorders, Multiple sclerosis (MS) unspecified
- Oncology, Blood & blood forming malignancies, Leukemia
- Psychiatry, Mood disorders, Depression
- Respiratory, Chronic obstructive airways disease, Chronic Obstructive Pulmonary Disease
Timeline
Sr Clinical Trial Manager
Syneos Health
12.2022 - Current
Clinical Trial Manager II
Syneos Health
09.2021 - 12.2022
Clinical Operations Lead
Syneos Health
07.2020 - 09.2021
Senior Clinical Research Associate II
Syneos Health
08.2015 - 07.2020
Clinical Research Associate II
inVentiv Health
05.2010 - 05.2013
Clinical Research Associate I
InVentiv Health
02.2008 - 04.2010
Clinical Research Associate I
Premier Research Group
01.2007 - 02.2008
Senior Clinical Research Assistant
Premier Research Group
08.2005 - 12.2006
Clinical Trial Assistant
GlaxoSmithKline
11.2002 - 01.2005
Bachelor - Cell Biology
Ludwig Maximilian Universitaet Muenchen