Overview
Work History
Education
Skills
Therapeuticexperience
Affiliations
Biography
Timeline
Generic

Felicia Dendy

Ellenwood,GA

Overview

30
30
years of professional experience

Work History

Sr. Clinical Trial Manager

Syneos Health
08.2020 - Current
  • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
  • Oversees site interactions post activation through site closeout, includes patient recruitment, investigator payments or other related activities
  • Responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
  • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters
  • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables
  • Manage project forecasting reports and maintained project tracking systems for subject visit activities, and site information, contract amendments, including review and approval processes
  • Escalates to project management and functional leads any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope
  • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
  • Participatr in technical reviews of large/high-risk projects; Bid defense and service capabilities presentations in support of Business Development
  • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
  • This may include accompanying CRA team members to sites for observation or conflict resolution
  • 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
  • Reviews and provides feedback on other functional plans (e.g
  • Data Management Plan, Communication Plan) as they relate to the clinical trial management activities
  • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan
  • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed
  • Ensures access and audit trail reviews are conducted as required
  • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study
  • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality
  • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
  • Reviews the project oversight dashboards and other clinical trial systems (e.g
  • Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan
  • Develop and implement a monitoring strategy required for the study, participates in the development of the study risk assessment plan
  • Is accountable for the assigned clinical team members' onboarding, study specific training, understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
  • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports 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
  • Document requested revisions and approvals in CTMS
  • Ensures deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
  • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables
  • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements
  • Provides solutions for obstacles in protocol execution and site management
  • Manage study specific contract vendors for study related services, tools and dashboards required for assigned use per trial
  • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA)
  • Supports Inspection Readiness for clinical trial management scope
  • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks
  • Develop and support execution of corrective action plans at site and study level
  • Supports and completes activities to achieve data cut, reconciliation for interim analysis and final data lock deadlines
  • Perform as Line Manager for direct reports for mid-level CTMs, CRAs and SMAs; wich also includes but not limited to mentoring of roles for career development, onboarding of team resources to specific trial programs/indications conducting performance reviews.

Project Manager

Covance
06.2018 - 06.2020
  • Responsible for project management of the assigned studies: plan, drive and track execution and performance of deliverables/timelines/results to meet country commitments; including from feasibility, trial/program budget planning, site selection, recruitment, execution and close out
  • Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT)
  • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, and quality standards
  • Manage post award, study start up development plans and implementation processes with study start-up teams
  • Manage contract budget allocations for outsourcing vendors, investigators, other external partners in assigned studies
  • Manage and coordinated external vendor activities with the clinical operations teams
  • Manage country, PI and Site feasibility processes, devised feasibility scoring tools for management of site selection and initiation processes
  • Participated in development of and review of study documents (Investigator Brochure, draft protocols, budget templates, CRFs, monitoring guidelines)
  • Develop and manage, design, implementation, tracking and revision of project plans for assigned projects (PMP, CMP, DMP, VMP)
  • Manage resources of staff allocation to assigned projects, ensure team training completed in alignment with professional standards, company SOPs and client/study specific training requirements
  • Manage and tracked project resource needs and contributed to contingency planning for key resources
  • Manage and developed project country enrollment plans; track country site
  • Manage Country study budgets including estimates and payments
  • Tracked client project metrics, schedule and conduct internal project review meetings
  • Manage project forecasting reports and maintained project tracking systems for subject visit activities, and site information, contract amendments, including review and approval processes
  • Conduct site invoice reviews, payments processing and disbursement tracing
  • Reviewed Monitoring Visits Reports, assessed site risks and performance issues for escalations of site issues and training to address performance issues if identified of CRA resources
  • Performed Quality Monitoring visits of CRA resources as required for quality monitoring assessment reviews
  • Identified and assessed risks, maintain associated documentation and tracked project progress against financial milestones
  • Lead the core project team, including CRAs, to facilitate risk monitoring and mitigation activities
  • Manage team input of identified risks, assigned level of importance and impact or risks for escalation and reporting to QA team and Sponsor, utilizing RACT tool
  • Ensured reporting of significant site issues in accordance with GCP guidelines, client and study specific Issue Escalation Plan and Safety Reporting Plan
  • Manage internal team notification, assigned monitoring team specific task activities per QA/QC plan
  • Participated in conduct of regulatory agencies and client driven site inspections
  • Participated in audit findings report reviews and response development for CAPAs with audit outcomes team
  • Manage processes and activities for Trial Master File documents indexing at study set-up and document collection and submissions requirements during study maintenance to study close met accuracy and audit readiness
  • Participated in data reviews for interim analysis, Manage clinical team activity for data query and protocol deviations resolution processes for interim analysis, database lock and elements of final CSR.

Sr. CRA Manager

ICON Clinical Research
10.2011 - 06.2018
  • Identify, select, initiate, and close-out appropriate investigational sites for clinical studies
  • Co-ordinate and participate in feasibility activities for countries and Principal Investigator Sites for new proposals
  • Participated in the preparation and review of study documents with cross-function teams (start-up, data management, pharmacovigilance)
  • Manage preparation of regulatory submissions; including timely submission of protocols/amendments country specific ICF documents, Safety Reports for IRB/IEC approvals
  • Manage pre-study placements and initiation visits for selected sites
  • Responsible for investigational site management including; recruitment/enrollment planning; site personnel training; assignment of CRA resources for site monitoring activities
  • Conducted new CRA training in alignment company SOPs and client/study specific training requirements, review of ICON systems and procedures
  • Developed and implemented a monitoring matrix training plan to assess the competence and knowledge of mid-level, in-training CRA’s
  • Conducted quarterly QCMV’s for direct report CRA’s
  • Manage internal team notification, preparation and participated in conduct of regulatory agencies and client driven site inspections
  • Participated in audit findings report reviews and response development for CAPAs with audit outcomes team
  • Manage Trial Master Files document submissions during study activity, met study requirements for audit readiness and archiving of files at study completion.

CRA II

i3 Research (Inventive Health)
09.2010 - 10.2011
  • Performed pre-trial assessments for site selection and start-up process, conduct routine site visits, including pre-study, initiation, interim, and closeout visits
  • Visits included monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures
  • Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
  • Reported to project team, client, and site personnel any findings noted at monitoring visit, by completion of monitoring reports and follow-up letters within the project-specific timelines
  • Ensured reporting of significant site issues in accordance with GCP guidelines, client and study specific Issue Escalation plan and Safety Reporting Plan
  • Maintained project tracking systems of subject and site information, contract amendments and site payments and processing
  • Participated in company and client directed training programs.

CRA II

Kendle International
04.2007 - 09.2010
  • Performed routine site visits, including pre- study, initiation, interim, and closeout visits
  • Visits included monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance
  • Reviewed subject records, essential documents, investigational product disposition and accountability, site personnel and procedures
  • Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
  • Reported to project team, client, and site personnel findings noted at monitoring visits
  • Completed monitoring reports confirmation and follow-up letters within the project-specific timelines
  • Maintained project tracking system of subject and site information
  • Participated in and conducted company-required and Sponsor study specific training
  • Performed necessary administrative functions (Expense report tracking, time and attendance).

Global Project Manager

Quintiles Laboratory (iQVIA)
10.2002 - 04.2007
  • Served as primary contact for Sponsors and vendors; liaised with senior management to ensure assignment of adequate resources for assigned projects
  • Selected and coordinated outsource vendors for provision of services with contract laboratories; developed global teamwork flows for presentation of services and interdepartmental tasks and responsibilities to clients
  • Interacted with internal and external vendors for global and regional coordination of project activities
  • Participated in technical reviews of large/high-risk projects; Bid defense and service capabilities presentations in support of Business Development
  • Provided input for Project Management Services for proposals and contracts for services and budget requirements
  • Collaborated on Scope of Work development and revisions for country and global trial activities
  • Developed and implemented project monitoring plans; developed and maintained communication and escalation plans for Sponsors and global teams; developed metrics and presented scheduled cost performance, study trends identified and budget analysis of study progression to estimated completion to Sponsor and global teams
  • Organized and lead team meetings for review of study status, milestones, and timelines
  • Generated status reports for both internal and external teams; conducted service training and instruction at Sponsor meetings
  • Manage team of global and regional assigned Project Coordinators and Project Assistant Staff.

Project Manager Associate

Clinimetrics Research Associates
08.1999 - 10.2002
  • Coordinated and Managed initial study start-up procedures for multiple Phase 1 - 4 clinical trials
  • Manage initial development and implementation of project Scope of Work and project costs/budgets for in-country and global trials
  • Performed site selection surveys, feasibility questionnaire development and scoring and conducted site qualifications interviews
  • Developed and implemented project monitoring plans; developed and maintained communication and escalation plans for Sponsors and global teams
  • Assisted with regulatory document preparation for site submissions of protocols, ICF, Patient materials to IRB/IEC
  • Created and maintained regulatory and clinical files to support sites and project management; created and implemented tracking procedures to document monitoring visit and regulatory submissions and approvals from IRB/IECs
  • Created and tracked processing of shipments including clinical supplies, CRF transmittals and regulatory documents for sites at study start-up
  • Prepared monthly reports of study progress and milestone completions for submission to Sponsors; conducted Quality Assurance audits per CRO and Client’s SOPs for all in-house regulatory documents
  • Completed design and production of CRFs and site management tools; performed data review of CRFs and generated data clarification requests
  • Facilitated communication with sponsors, sites, CRAs, and vendors to ensure effective project management
  • Created and implemented management tools for documenting and tracking collected data for data cleaning, reporting and interim analysis activities
  • Performed routine site monitoring visits as a CRA including pre- study, initiation, interim, and closeout visits
  • Visits included monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance.

Pharmacy & Nursing Administrative Assistant

New England Medical Center (TUFTS)
03.1995 - 10.1997
  • Manage daily operations for Pharmacy & Nursing directors
  • Maintained and generated data reports for patient services which included analyzing cost center budgets vs
  • Patient occupancies
  • Assisted with technical support of department budget systems.

Research Administrative Coordinator

Brigham & Womens Hospital Research
10.1994 - 02.1995
  • Provided support for development of Protocols and Investigator Brochure
  • Assisted with production and revision of study manuals and data collection forms
  • Assisted with development, review and implementation of SOPs for research team
  • Assisted data team with procedures for randomization of research participants
  • Produced and distributed reports and study updates for participating resource physicians and vendors
  • Responsible for scheduling research protocol review meetings.

Education

Bachelor - Human Services - Human Services, Clinical Social Work

Northeastern University
United States
09.1994

Skills

  • ICH/GCP Knowledge
  • Adverse event reporting
  • Clinical Data Management
  • Training and mentoring
  • Clinical Trial Oversight
  • Business Development
  • CRA Monitoring
  • Patient recruitment
  • Customer Focus
  • Clinical Supplies Management

Therapeuticexperience

  • Real World Evidence/ Late Phase Trials
  • Non-interventional studies (NIS) / Observational Studies
  • Post-authorisation safety studies (PASS) / Post-authorisation efficacy studies (PAES)
  • Registries
  • Cardiovascular
  • Amyloidosis
  • Arterial Disease, Peripheral
  • Arterial Disease, Renal
  • Atherosclerosis
  • Heart Failure, Chronic
  • Hypertension, Pulmonary Arterial
  • Hypertension, Resistant
  • Thrombosis, Post-Surgical
  • Dermatology
  • Psoriasis
  • Psoriatic Arthritis
  • Device
  • Coronary Artery Disease Device
  • Endocrinology/Metabolism
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Dyslipidemia
  • Hyperparathyroidism, Secondary
  • Lipodystrophy
  • Weight Loss
  • Gastroenterology
  • Colitis
  • Crohn's disease
  • Diarrhea, HIV-Related
  • Irritable Bowel Syndrome
  • Immunology / Inflammatory
  • Autoimmune Diseases
  • Infectious Disease
  • Immunization, Anthrax
  • Infection, Aspergillosis
  • Infection, Clostridium Difficile
  • Infection, Hepatitis B
  • Infection, Hepatitis C
  • Infection, Human Immunodeficiency Virus
  • Inflammatory Diseases
  • Arthritis
  • Nephrology
  • Kidney Disease, Chronic
  • Renal Failure, Chronic
  • Neurology
  • Neuromuscular Disease
  • Rare Disease
  • Oncology
  • Cancer, Advanced Solid Malignancies
  • Cancer, Basal Cell Carcinoma
  • Cancer, Breast
  • Cancer, Glioblastoma
  • Cancer, Hematologic Malignancies
  • Cancer, Lung Non Small Cell
  • Cancer, Lymphoma
  • Cancer, Metastatic Solid Tumors
  • Cancer, Non-Hodgkins Lymphoma
  • Cancer, Refractory Solid Tumors
  • Cancer, Refractory Tumors
  • Cancer, Squamous Cell
  • Study Design
  • Antibodies, monoclonal antibodies
  • Oncology Biomarker
  • Oncology Companion Diagnostic
  • Laboratory Experience
  • Project management
  • Budget administration
  • Functional and Financial Planning
  • Project planning & reporting
  • Pharmacodynamics
  • Pharmacokinetics
  • Safety
  • Safety pharmacology
  • Languages
  • English - Speaking, Reading, Writing - Native
  • Additional Experience
  • CRA Trainer/Assessor
  • Electronic Diaries
  • Electronic TMF review
  • EConsent
  • Study Design/Type Experience
  • Cancer,Dose Escalation
  • Cancer,Dose Ranging
  • Cancer,Pharmacodynamic
  • Cancer,Pharmacokinetic
  • Coagulation
  • Dose Escalation
  • ECG
  • Investigator Initiated Trials
  • Renal Impairment
  • Transplant
  • Stem Cell

Affiliations

ACRP - Professional PM/ CRA - Member Since Jun-2015

Biography

I am an experienced Sr. Clinical Research Trial Manager with 30 year(s) of experience in the Contract Research Organization (CRO) Industry including as a Global Project Manager for 13 years, Sr. CRA for 8 years in Phases 1 - IV, and 4 years as, Sr. Clinical Trial Manager in RWLP/NIS and 5 years as an Associate Clinical Research Data Manager. I have experience in managing global interventional and non-interventional studies with various designs: Early Clinical Development, Phase IV interventional, Outcomes Studies, Expanded Access Programs and Randomized Controlled Studies. As well as, prior experience in managing and monitoring studies in Phase I to IV. In my clinical research positions held, have afforded me to accumulate extensive experience in therapeutic areas of Oncology, Infectious Diseases, Endocrinology, Cardiovascular disease and disorder, Immunological diseases and disorders, Gastroenterology, Rare disease, Dermatology and Medical Device. These experiences have culminated in my, being a key contributor into Real World Evidence, Real World Data Analytics, Call Center, Fit-for-purpose Site Management, RWE Electronic Data Capture technology, Direct Data Capture, Digital Patient Engagement, Direct to Patient Collection, Telehealth, Home Nursing, Wearables and Devices. Implementation of innovation, digital health technology via a dynamic assembly approach, and data driven decisions allows me the ability to positively impact and create added value to assigned studies in the form of accelerated timelines, cost reductions, enhanced site and patient engagement, patient diversity, and optimal data quality. I am based in Atlanta, Georgia.

Timeline

Sr. Clinical Trial Manager

Syneos Health
08.2020 - Current

Project Manager

Covance
06.2018 - 06.2020

Sr. CRA Manager

ICON Clinical Research
10.2011 - 06.2018

CRA II

i3 Research (Inventive Health)
09.2010 - 10.2011

CRA II

Kendle International
04.2007 - 09.2010

Global Project Manager

Quintiles Laboratory (iQVIA)
10.2002 - 04.2007

Project Manager Associate

Clinimetrics Research Associates
08.1999 - 10.2002

Pharmacy & Nursing Administrative Assistant

New England Medical Center (TUFTS)
03.1995 - 10.1997

Research Administrative Coordinator

Brigham & Womens Hospital Research
10.1994 - 02.1995

Bachelor - Human Services - Human Services, Clinical Social Work

Northeastern University

Similar Profiles

CREATE PROFILE
Felicia Dendy