Jennifer Appleby
New Braunfels,TX
Summary
Dedicated and focused Project Manager with 16+ years of achievements in the pharmaceutical industry, with international experience in various therapeutic areas, including oncology and rare diseases. Combines resourcefulness, problem-solving skills and clinical knowledge to consistently deliver high-quality results. Solid interpersonal skills, combined with strong leadership skills used to communicate, train, and provide concise reports and updates to upper management, large groups, and individuals.
Overview
14
14
years of professional experience
Work History
Project Manager
ICON Clinical Research
Raleigh, NC
02.2023 - Current
- Recognize, exemplify and adhere to ICON's values, which center on our commitment to People, Clients and Performance
- Act as primary liaison with client
- Understand/manage/satisfy client contractual, organizational and relationship needs/expectations
- Management of project costs and control of financial risk
- Proactive identification of out-of-scope activities and implementation effective change control
- Proactive risk/issue identification and mitigation through ongoing review of project progress and metrics
- Responsible for implementation of adequate follow-up actions and to act as a point of escalation for project teams
- Management of project timelines and contractual deliverables
- Lead and direct cross-functional team leaders and third parties/vendors
- Provide regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client
- Facilitate the definition of project scope, goals and deliverables
- Define project tasks and resource requirements
- Develop full-scale cross-functional project plans
- Assemble and coordinate project staff
- Provide direction and support to project team
- Quality assurance
- Constantly monitor and report on progress of the project to all stakeholders
- Present reports defining project progress, problems and solutions
- Implement and manage project changes and interventions to achieve project outputs
- Project evaluations and assessment of results
Senior Clinical Trial Manager
ICON Clinical Research
01.2021 - 02.2023
- Acted as the Global Clinical Trial Manager and Led clinical resources in a matrix environment, as required, including regional Clinical Trial Managers, Clinical Trial Assistants and Clinical Research Associates
- Responsible for coordinating and managing the clinical project team to ensure high performance and productivity (e.g
- DOS for CRAs), optimal utilization, minimal turnover and all necessary project training were provided, documented and filed appropriately
- Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including issue escalation and resolution
- Responsible for the development and maintenance of operational plans for clinical deliverables e.g
- CRF completion guidelines, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc
- Ensured the core clinical portions of the Trial Master File were up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary
- Ensured all close-out activities were completed as necessary e.g
- End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized, and all action items resolved
- Led and/or actively participated in the conduct of clinical team meetings
- Ensured timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables
- Implemented QC activities, ensured compliance with quality measures and monitored required quality metrics
- Acted as a Source Matter Expert on MMSEA reporting for the sponsor business unit
- Created presentation on the topic and presented to CTMs and PMs on the process per SOP and regulations, managed tracker with input for CTMs/PMs in unit on reportable events, reviewed entries and provided details to sponsor as required to ensure compliance with sponsor SOP and applicable laws
- Developed staff skills, encouraged career growth and provided regular performance feedback
- Acted as a mentor and helped to train junior staff
- Communicated expectations, setting clear goals and objectives for the study to clinical team members
- Ensured teams were aware of progress to goals and against expectations
- Led by example and motivated all assigned team members
- Built and maintained strong relationships with trial investigators, sponsors and vendors
Clinical Operations Lead
Syneos Health
Morrisville, NC
06.2019 - 01.2021
- Responsible for site management oversights, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
- Oversaw site interactions post activation through site closeout, to include patient recruitment, investigator payments and other related activities
- Reviewed the study scope of work, budget and protocol content and ensured the clinical project team (CRAs) were aware of the contractual obligations and parameters
- Escalated to project manager any risks to clinical trial management deliverables (timeline, quality, budget) and any activities and requests which are out of contracted scope
- Employed strategic thinking and problem-solving skills to propose and implement risk mitigations
- Coordinated initial and ongoing training to the study team regarding protocol specifications, CRF completion, dashboards, clinical plans and guidelines, data plans and timelines for the study
- Led and oversaw clinical teams, including Site Management, performance, and corresponding documentation
- Managed and coordinated Clinical Research Associates (CRAs)/Central Monitoring Associates (CMAs) on clinical research projects
- Served as line manager for CRA Direct Reports
- Reviewed 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 and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity
- Documented requested revisions and approvals within CTMS
- I interacted with the client and other functional departments related to clinical monitoring and site management deliverables
- Provided status updates on the clinical deliverables and risks to the client, project management and leadership as per departmental or study agreements
Clinical Trial Manager
ICON Clinical Research
Raleigh, NC
12.2017 - 06.2019
- Acted as functional lead from clinical operations with oversight of, and overall accountability for site selection, site initiation, patient recruitment, site monitoring, data retrieval and study close-out
- Responsible for risk mitigation strategies, associated action plan and issue resolution, and contributions to the cross-functional project management plans
- Overall responsibility for managing the clinical operations project team and ensuring compliance with SOPs, study contracts, budgets and quality standards
- Created tools to provide guidance for CRAs regarding visit requirements/report writing
- Reviewed monitoring reports and provided feedback to CRAs
- Provided instruction to both on-site and in-house CRA teams
- Reviewed and provided input on monitoring plan
- Led bi-weekly team CRA calls and trained CRAs on new study requirements
- Worked closely with the project manager, global CTM, sponsors and vendors to discuss study concerns, along with possible resolutions to issues
- Reviewed and approved site payments
- Prepared for and presented at Investigator Meetings
Clinical Research Associate II
ICON Clinical Research
Raleigh, NC
02.2016 - 12.2017
- Completed onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes
- Activities included qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out
- Verified the protection of study participants by confirming informed consent procedures and protocol had been performed in accordance with applicable regulations
- Ensured the integrity of clinical data and that the study was conducted in compliance with approved protocol, GCP, applicable regulations and SOPs
- Managed the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables
- Verified proper management and accountability of Investigational Product (IP)
- Wrote and submitted reports of investigational site findings and updates applicable tracking systems
- Escalated observed deficiencies, issues, and corrective and preventative action plans as appropriate
- Managed essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study
- Assisted with resolution of investigational site/data queries
- Performed key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation
- Participated in audit preparation and follow-up activities as needed
- Gathered and reviewed information for assigned sites and identifies inconsistencies
- With guidance from project and functional management, assesses risk and escalates as appropriate
- Assisted with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives
- Served as preceptor, providing training to less experienced clinical team members
- Prepared for and presented at Investigator Meetings
Clinical Research Associate I/II
NewLink Genetics
Austin, TX
10.2014 - 02.2016
- Performed and coordinated all aspects of clinical monitoring and site management
- Assured adherence to Good Clinical Practice, Investigator integrity, and compliance with all study procedures
- Conducted site evaluation and monitoring visits
- Verified data with source documentation
- Wrote visit reports and followed up with sites to verify completion of necessary tasks
- Trained new clinical research associates
- Contributed to the development of study-specific documents such as CRFs, SIV slides and agenda, Monitoring Plan, Lab and Procedure Manuals
- Provided input on needed provisions to the protocol
- Confirmed eligibility of subjects enrolled while on site
Clinical Research Associate I
Pharmaceutical Product Development LLC
Austin, TX
05.2013 - 10.2014
- Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and Client Company SOPs prior to submission to project manager, central IRB, regulatory affairs and/or client
- Identified regulatory issues by performing ongoing TMF reviews and worked with monitor and investigator sites to resolve
- Coordinated, oversaw, and completed all administrative functions on assigned trials, to include, but not limited to, review and transmission of regulatory files
- Provided support to Program Managers and other team personnel as needed to comply with contract deliverables
- Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products
- Participated in reviews of Mock Screen Layouts, Data Specification Tables and Electronic Edit Checks for all studies performed outside of the PPD Phase I Clinic
- Maintained TMFs
- Conducted site visits, including initiation and interim visits in accordance with ICH/GCPs, SOPs, and FDA guidelines
- Composed monitoring guidelines that outlined how the study will be monitored from start to finish
- Created site initiation presentations
Associate Quality Control Auditor
Pharmaceutical Product Development LLC
Austin, TX
03.2011 - 05.2013
- Monitored data collection sheets, protocols, CRFs, Adverse Event reports, laboratory reports, procedural documents, Informed Consent forms and other study related documents to ensure accurate and complete capture and documentation of the study conduct was achieved in the study records
- Ensured data would pass quality assurance audits
- Reviewed screening information to ensure documentation was present in the subject file to confirm/deny the subject’s eligibility in the study per protocol criteria
- Communicated audit findings via a QC report per study and relayed any other questions and/or concerns in a timely fashion to the project manager, investigator and/or study team members
- Escalated critical observed deficiencies/issues to management
- Reviewed study specific recruitment questionnaires prior to submission to IRB for approval
- Approved lab testing to ensure it matched protocol
Research Team Clinical Coordinator
Pharmaceutical Product Development LLC
Austin, TX
11.2010 - 02.2011
- Created source documents and prepared all study supplies
- Scheduled bed space, PI time, meals, and laboratory collections with appropriate departments
- Served as primary liaison to study subjects, answering questions and concerns regarding all aspects of study participation
- Collaborated with study recruiter to confirm all subject eligibility criteria were met, including signature of most recent informed consent form
- Ensured subject compliance and timely communication of issues to team leader and project management
- Consulted with PI during his/her review of laboratory reports, ECGs/telemetry, AEs and physical exams
- Updated and verified adverse events throughout the duration of the study while communicating with the team leader, project manager, and principal investigator as to appropriate courses of action
- Dosed investigational product after review of randomization schedule, AE database, and any other pre-doses safety measures
Education
Bachelor of Arts - Psychology
The Ohio State University
08.2024
Skills
- Effective Communication
- Team Leadership
- Versatile Approach
- Project Oversight
- Stakeholder Relationship Management
- Process Optimization
Therapeutic Areas
- Rare Diseases and Disorders (Hemophilia B, Ankylosing Spondylitis)
- Oncology (Melanoma, Glioblastoma, Non Small Cell Lung Cancer, Pancreatic, Prostate)
- Autoimmunity (Systemic Lupus Erythematosus)
- Vaccines (COVID-19)
- Dermatology (Atopic Dermatitis)
- Hepatology (NASH)
- Gastroenterology (Irritable Bowel Syndrome, Gastroesopegheal Reflux Disorder)
- Inflammation/Immunology
References
References available upon request.
Timeline
Project Manager
ICON Clinical Research
02.2023 - Current
Senior Clinical Trial Manager
ICON Clinical Research
01.2021 - 02.2023
Clinical Operations Lead
Syneos Health
06.2019 - 01.2021
Clinical Trial Manager
ICON Clinical Research
12.2017 - 06.2019
Clinical Research Associate II
ICON Clinical Research
02.2016 - 12.2017
Clinical Research Associate I/II
NewLink Genetics
10.2014 - 02.2016
Clinical Research Associate I
Pharmaceutical Product Development LLC
05.2013 - 10.2014
Associate Quality Control Auditor
Pharmaceutical Product Development LLC
03.2011 - 05.2013
Research Team Clinical Coordinator
Pharmaceutical Product Development LLC
11.2010 - 02.2011
Bachelor of Arts - Psychology
The Ohio State University