Diane Esserry
Saddle Brook,New Jersey
Summary
Study Data Manager with eighteen years of experience in the pharmaceutical and hospital industries managing in-house and outsourced studies. Detail oriented with excellent communication and collaboration skills. Ability to work with local and global teams with the emphasis on achieving focus results.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Senior Lead Data Manager
PRA/ICON
01.2021 - 01.2022
- Leads all the data management tasks in support of Phase I – IV gene therapy clinical studies from study start-up to database lock
- Leads all the study specific Clinical Data Management (CDM) tasks performed by the DM CRO
- Delegates tasks to the CDM team members and vendors and monitor progress
- Plans and facilitates internal CDM study meetings
- Leads development and ensure consistency of study specific Data Management Plans, Vendor Management Plans, Cross-functional Data Review Plans, eCRF Completion Guidelines, eTMF documents and other CDM documents as appropriate
- Leads development and implementation of Data Transfer Specifications in collaboration with vendors and cross-functional team members
- Reviews clinical protocols and provides input based on CDM best practices
- Facilitates cross-functional data review for assigned study
- Leads User Acceptance Testing for clinical study database
- Leads data review for accuracy, completeness and consistency and performs QC as appropriate
- Represents CDM at the cross-functional study team meetings
- Adheres to study and program timelines.
Clinical Data Manager
TKL Research, Inc.
01.2014 - 01.2021
- Perform the design, specifications, creation and validation of a clinical database
- Develop and create case report forms (paper or electronic) and other source data for data entry based on specific protocols
- Work closely with Project Management, Biostatistician and Quality Assurance team
- Create and maintain clinical database for paper-based studies
- Oversee the database development activities for EDC studies
- Work with Data Entry group to review specific data entry guidelines, database validation testing, entry of test data, restrictions and entry of production data including issues and trends for paper studies
- Create, maintain and implement Data Management Plan
- Collaborate with programmer on edit checks and study specific manual listings
- Review edit checks, data listings and manual review of CRFs to generate, issue, track and resolve discrepancies in a timely manner
- Perform coding of adverse events and concomitant medications
- Develop data transfer specifications (DTS) to manage working with external vendors, ensure data is transferred according to the specifications, reconcile data with clinical database
- Work closely with Data Managers from Cognizant
- Provide guidance to other team members.
Clinical Data Manager
Eisai Pharmaceutical
01.2012 - 01.2014
- Work on Phase I-III Oncology trials with strong data management and excellent interpersonal skills to independently manage DM activities on Phase I trials
- Independently perform all data management activities to ensure timely and quality database lock
- Perform SAE Reconciliation, Metric Reports, LNR review, Listing review and Auto query review, Patient Profile review comments
- Work closely with ClinOps team to ensure deliverables are met according to timelines
- Worked on Phase III study closeout activities, freezing patients, locking patients, suggested improvements to Programming to reduce manual review and enhance quicker review
- Liaise with External Vendors to achieve data lock timelines and ensure database lock timelines are met
- Manage reconciliation of External Data (ECHO, Biomarkers, Imaging Scans).
Study Data Manager
Hoffmann La-Roche
01.2009 - 01.2012
- Led the Clinical Data Management (CDM) study team and maintained oversight of all activities for assigned Phase I Oncology studies
- Collaborated with Case Report Form (CRF) Designer and Clinical Programmer (CP) to design databases that adhere to protocols as well as company standards
- Worked closely with external Clinical Programmers to create and test database according to study timelines prior to first patient first visit
- Created and maintained Data Quality Plan including Data Validation Checks Specifications, Data Review Plan, Study Assumptions, Macro Study Definition Specifications (MSDS), Study Specific Conventions and User Acceptance Testing (UAT) Script to comply with regulatory standards
- Liaised with Program Data Leader (PDL) on decisions made by Global Study Management Team (SMT) related to Data Management resources planning, timelines, risk management and quality plan at study level
- Worked with Global Team to manage the delivery of Data Management activities to meet study timelines such as guidance for Amendments, Database Snapshots and Study Closeout
- Represented Clinical Data Management at Study Management Team Meetings providing site connectivity, metrics and discrepancy management
- Properly escalated study issues and, as needed, corrective action plans in place
- Identified areas of best practices and process improvements and adheres to project standards by scheduling Live Meetings with external Clinical Programmers to review database updates based on Amendments, color coding new edits in the Data Validation Checks (DVC) Specifications document for easy identification by the Clinical Programmers
- Built relationships with study team and monitors.
Data Manager
Hoffmann La-Roche
01.2004 - 01.2009
- Reviewed and processed clinical trial data to ensure accuracy and consistency of clinical database
- Assisted in the training and transitioning of an in-house study to a Business Process Outsourcing (BPO); Provided Quality Checks of the external Data Managers at Tata Consultancy Services (TCS) using a graded score card to measure understanding of the protocol, all data management documents and the tools used for data cleaning
- Handled and managed resolution of discrepancies within the allocation timeframe
- Managed high volume of interaction with monitors via telephone and email to resolve any errors, omissions, or inconsistencies found during data review
- Tracked data received via Case Report Forms (CRFs) for in-house review through use of Case Report Forms tracking sheets
- Performed quality checks of the clinical trial database against the Case Report Forms and resolved queries for adherence to protocol requirements
- Updated clinical trial database to correct any erroneous data that is identified during data entry
- Collaborated with Study Coordinators, Monitors and Country Study Managers (CSMs) for assigned sites to ensure timely delivery of clean data for Interim Analysis and Database Locks
- Tracked and maintained data management reports on data review including Missing Pages, Outstanding Discrepancy Reports and Overdue Visits
- Archived data management study documents.
Data Coordinator
Hackensack University Medical Center
01.2003 - 01.2004
- Participated in the conduct of Pre-study, Site Initiation, Monitoring and Close-Out Visits of all Multiple Myeloma Clinical Trials
- Completed all data collection requirements for Case Report Forms, submission of patient dairies and calendars
- Handled updating of Case Report Forms
- Submitted, logged, tracked and maintained site related essential documents such as Case Report Forms source documents, Lab Certification, Investigator Medical Licenses, Curriculum Vitae (CV), Food and Drug Administration (FDA) 1572 Forms, Financial Disclosure Forms, Informed Consents, Institutional Review Board (IRB) Submission documents, Investigational New Drug (IND) Safety Reports, Serious Adverse Events/Adverse Events Reports (SAE/AE) and Confidentiality Agreements
- Served as liaison between Pharmaceutical sponsors and Hackensack University Medical Center Multiple Myeloma protocols
- Oversaw shipment of mandatory study specimens to various laboratories
- Worked closely with Research Coordinator and Principal Investigator
- Experienced with audits on clinical trials
- Managed compliance with local regulatory requirements, International Conference on Harmonization (ICH), Good Clinical Practice and Standard Operating Procedure guidelines.
Unit Coordinator
Hackensack University Medical Center
01.2000 - 01.2003
- Oversaw daily and weekly clerical duties on the Stem Cell Transplant Unit
- Maintained inventory and order supplies cost effectively
- Provided adequate care of patients’ medical charts for admissions, transfers to other units and discharges
- Administered physician's orders for patients, such as blood work, pharmacy orders, dietary orders and special laboratory tests
- Ensured the policies and confidentiality of the patients were maintained.
Education
Ramapo College of New Jersey
Mahwah, New Jersey12.1995
Skills
- ClinPlus 34
- DSG eCaseLink 80
- Medidata Rave X
- SAS
- Oracle Clinical
- InForm 46, 51
- Clintrial
- MACRO (Roche EDC System)
- J-Review
- Hyperion
- Microsoft Office (Word, Excel, Power Point)
- Veeva Vault
- BOX
- Elluminate
Certification
- Certified in the Protection of Human Subjects
- Certified in the Health Insurance Portability & Accountability Act (HIPAA) for Clinical Trials
- Certified in the Handling and Shipping of Dangerous Goods
Relevant Training
- Introduction to Drug Development course
- Project Management for Study Data Managers course
- Oracle Clinical e-Learning
- MACRO electronic data capture system training
- ECaseLink electronic data capture system training
- RAVE electronic data capture system training
Therapeutic Experience
- Dermatology
- Oncology
- Diabetes
- Rheumatoid Arthritis
- Sickle Cell Disease
Timeline
Senior Lead Data Manager
PRA/ICON
01.2021 - 01.2022
Clinical Data Manager
TKL Research, Inc.
01.2014 - 01.2021
Clinical Data Manager
Eisai Pharmaceutical
01.2012 - 01.2014
Study Data Manager
Hoffmann La-Roche
01.2009 - 01.2012
Data Manager
Hoffmann La-Roche
01.2004 - 01.2009
Data Coordinator
Hackensack University Medical Center
01.2003 - 01.2004
Unit Coordinator
Hackensack University Medical Center
01.2000 - 01.2003
Ramapo College of New Jersey