Clinical Data Management Specialist with Team Leadership
Resume:
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CONTACT
Pottstown, United States *****
*************@*******.***
SKILLS
Effective relationship management
Collaborative teamwork
Team leadership
Process optimization
Guiding team members
Client interaction
Strategic business development
Data gathering and analysis
Collaborative teamwork
Detail-oriented approach
Clear communication
Responsive to evolving challenges
Employee training
CERTIFICATIONS
ICH GCP Training
Regulatory Filings and Applications
Vendor Oversight
Drug Development and Clinical Trial Processes
Systems Development Lifecycle
Data Management Processes
Project Planning and Management
SCDM – Society for Clinical Data Management
LANGUAGES
English
THERAPEUTIC EXPERIENCE
Heart Failure, I, 10 Years, USA, Scotland, Japan, Data Management/Monitoring
Angina Pectoris, II, 4 Years, USA, Scotland, Data Management/Monitoring
Liver Disease and Cirrhosis, II, 4 Years, USA, Data Management/Monitoring
Diabetes Mellitus, I, 7 Years, USA, England, Data Management/Monitoring
Renal Failure, II, 3 Years, USA, Data Management
Coagulation Defects, I, II, 6 Years, USA, Data Management
HIV, II, 2 Years, USA, Data Management
Hepatitis C, II, 3 Years, USA, Data Management
Schizophrenic Disorders, III, 4 Years, USA, Data Management
Osteoporosis, I, 2 Years, USA, Data Management
Alzheimer's, II, 3 Years, USA, England, Data Management
Acute Myeloid Leukemia, I, II, 5 Years, USA/EU, Data Management
Breast Cancer, II, 4 Years, USA/EU, Data Management
Multiple Myeloma, II, 5 Years, USA/EU, Data Management
Clostridium Difficile, II, 2 Years, USA, Data Management
Rheumatoid Arthritis, I, II, 4 Years, USA, Data Management
Erectile Dysfunction, II, 3 Years, USA, Data Management
Pneumococcal Vaccines, I, II, 5 Years, USA, Data Management
Asthma, I, II, 10 Years, USA, Data Management
Covid-19, I, II, III, 3 Years, USA/EU, Data Management
Device, 7 Years, USA/EU, Data Management
Ophthalmology, I, II, 2 Years, USA/Global, Data Management
Management professional with solid history in directing operations and guiding teams to success. Known for collaborative leadership and achieving significant results in dynamic environments. Recognized for strategic decision-making and adaptability to changing business needs. Experienced with leading management initiatives and driving team performance. Utilizes strategic planning to optimize operations and achieve business goals. Twenty-six year track record of fostering collaboration and innovation in high-performing teams.
WORK HISTORY
April 2023 - November 2025
Associate Clinical Data Management Director IQVIA US
Oversight for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction
Provide expert skills as part of a Clinical Data Management team to provide efficient, quality data management products that meet customer needs
Provide leadership to the DM team in the area of project planning and execution, financial management, communications, risk assessment and milestone tracking
Viewed as an expert in data management and for a designated Therapeutic Area
May perform role of Senior Lead Data Manager / customer site lead, responsible for managing and delivering program of studies for a customer
Provide leadership and senior support to a team of Principals and Lead Data Managers on multiple large global studies / programs of global studies. Act as the main overall point of contact for internal and external customers for program/ multiple projects
Manage relationship with a customer on a DM level. Manage delivery of multiple projects / programs through the full data management study life cycle independently, from Request for Information/Proposals, Bid-defense, Client Alignment Meetings to Qualification audits and Archival. Independent management of program / project timelines, quality, resources, SOW (scope of work) / budgets
Lead DM customer negotiations on complex timeline, budgetary and other issues
May serve as Project Manager for single service data management projects
Manage comprehensive data management tasks pertaining to the Data Management Plan
Manage comprehensive quality control procedures. Provide data management expertise and data coordination, process improvements to CDM management
Mentor other team members in training and developing data management expertise
Independently bring project solutions to the CDM team and the CDM Department
Manage the development and implementation of new technology/tool
Present at professional conferences and/or publish articles in professional journals
Provide Data Management with technical expertise
Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions
Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team
Implemented strategic initiatives to improve client engagement and satisfaction metrics.
Cultivated relationships with key clients, driving long-term partnerships and business expansion opportunities.
Managed cross-functional teams to successfully execute complex projects on time and within budget constraints.
Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
June 2022 - Current
Director, Clinical Data Management TFS Health Science, Princeton, US
Oversee day-to-day data management operations and staff
Serves as subject matter expert during client and vendor meetings where needed
Actively supports business development in capabilities presentations to prospective and current clients
Primary contact for department and clinical study budgets
Responsible for North America FSP and Single Service Projects
Serves as Project Manager on clinical studies, as needed
Works closely with Executive Leadership to mentor data management staff
Ensures project work is planned, resource allocated and is successfully executed
Provides direction to staff when issues arise that the staff cannot resolve on their own
Ensured proper training and development of staff
Conducted regular meetings and completes year-end performance reviews with all direct reports
Monitors performance of team and initiates process and resource improvement in partnership with Director of TFS Business Unit
Adhered to all aspects of the company's quality system
Complies with the company's data integrity and business ethics requirements
Performs other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at TFS to maintain compliance to business and regulatory requirements
A proactive and independent thinker in problem solving; ability to anticipate data management related problems with the ability to recommend creative technical solutions to avoid potential issues
Advanced knowledge of CDM processes, systems, and technology advancements
Proven leadership and management skills to lead Data Management group and the ability to hire and develop team members
Works with the existing Data Management FSP teams in supporting ongoing studies
Represent Biometrics as the subject matter expert in Clinical Data Management by providing strategic planning and tactical direction for Clinical Data Management activities across all projects in all phases of development
Provides oversight of and guidelines to CROs to ensure timely delivery and regulatory compliance of outsourced activities, may oversee CROs' data management function inspections and audits
October 2020 - June 2022
Manager, Clinical Data Management Statistics and Data Corporation, Tempe, AZ
Oversee day-to-day data management operations
Serves as subject matter expert during client and vendor meetings
Actively supports business development in capabilities presentations to prospective and current clients
Effectively provides input for department and clinical study budgets
Liaises with internal and external cross-functional teams, sponsors, vendors, etc.
Serves as Project Manager on clinical studies, as needed
Works closely with Director of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff
Ensures project work is planned, resource allocated and is successfully executed
Provide direction to staff when issues arise that the staff cannot resolve on their own
Ensured proper training and development of staff
Conducted regular meetings and completes year-end performance reviews with all direct reports
Monitors performance of team and initiates process and resource improvement in partnership with Director of Data Management
Adhered to all aspects of the company's quality system
Complies with the company's data integrity and business ethics requirements
Performs other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
August 2019 - October 2020
Senior Data Management Lead PAREXEL International, Decentralized, PA
Overall accountability for execution of Data Operations strategy and Data Operations' Technology setup for a project as well as Data Operations budget development and oversight for scope considerations.
Provides overall leadership / management for database programming, data integration, and data processing on a project / program using Datalabs and RAVE EDC systems.
Participate in global initiatives for DM process improvement activities including SOP review for quality improvement and streamlined workflows.
Coordinate Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders and the client as a single point of contact to ensure that Data Operations deliverables with regards to timelines, quality, and productivity are being met.
Acts as Project Leader for projects involving a small number of services, where no Project Leader is assigned.
Mentor junior Data Operations Leaders in order to achieve departmental objectives as well as quality of work.
Participate in Bid Defense Meetings and ad hoc proposal related sponsor discussions.
June 2018 - July 2019
Data Management Project Lead/Clinical Data Management Manager DOCS Global Inc. / ICON, Decentralized, PA, US
Ensuring clinical projects are executed according to set timelines with quality and consistency
Leading DM activities for a given product or multiple products
Ensuring that DM procedures and processes are adhered to by FSP staff through oversight of quality, cycle times, metrics and use of the issue CAPA process
Coordination and mentoring of lead data managers within assigned projects
Training and mentoring of DM TA staff on processes, projects and programs
Lead or participate in development. review and implementation of processes, policies, SOPs and associated documents affecting OM
Participate in and/or lead DM and cross functional working groups
Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners and external vendors
Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics
Promote and be an advocate of DM internally and externally
Represent DM at project team meetings i.e., GCST
Project level coordination of and day to day oversight of OM tasks including: Co-ordination of lead DM's within the project
Review of all DM documents within a project area to ensure a consistent approach
Overview of project timelines and metrics to ensure databases are delivered to set timelines
Approve database locks and unlocks
Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards
Provide DM product level input to developing and managing resource plans and budgets for DM
Ensure that quality control checks are occurring such that quality databases are delivered
Develop and co-ordinate project level training for data management staff
Review and approve study specific training
Manage vendor deliverables and relationship at the project level
Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
Review of all study level non- DM documents for awareness and project level consistency
Lead electronic submission activities
Assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study I vendor level
November 2014 - June 2018
Principal Clinical Data Manager / Manager, Data Management PPD, Decentralized, PA, US
Manage all operational aspects of clinical trials in compliance with GCP regulations.
Review and manage project budgets, timelines and resources across Client programs and studies.
Ensure and create timelines of deliverables for each phase of the study from study start-up through production and close-out activities.
Oversee all start-up, maintenance and close-out activities along with UAT
Act as the Study Manager for one or more studies, responsible for customer contact, functional, administrative and financial oversight for allocated projects.
Perform the Project Management role for projects without clinical services, or act as a Clinical Data Management Franchise Lead.
Ensure the set-up activities for a study are performed correctly and in a timely manner.
Perform study specific training and ensure staff are following current procedures.
Represents Clinical Data Management at internal and external meetings and presentations.
Travel to and from Investigator Meetings when needed along with requested client meetings and BID Defense.
Create new Working Procedures and update SOPs when needed.
Main point of contact for Data Management for the client and vendors being used.
Review and help create SOW for contract purposes and proposals.
Oversight of Third Party Vendors
Oversight of Data Management Leads and Data Reviewers.
Responsible for biweekly 1:1 with staff and Direct Reports to ensure all tasks are being completed.
Responsible for 6 month and yearly staff performance evaluations of staff.
Responsible for Direct Reports Resource Availability and Study Allocations.
Responsible for Direct Reports and staff Training Compliance.
Responsible for making sure staff needs are within Budget.
Main point of contact for any Study escalations that may arise.
February 2012 - November 2014
Trial Manager/PDM — Project Data Manager PRA, Blue Bell, PA, US
Manage all operational aspects of clinical trials in compliance with GCP regulations.
Review and manage project budgets, timelines and resources across Client programs and studies.
Ensure timelines of deliverables for each phase of the study from study start-up through production and close-out activities.
Ability to multi-task.
Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding and Site Personnel.
Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion for any findings in the INFORM EDC system.
Participate in study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
Escalate any potential or actual issues to supervisor, project team, and/or Client Company in a timely manner, and follow issues through resolution.
Provide written project status reports to Client Company and verbally present as necessary at Client Company meetings.
Delegate or assist with delegating daily tasks for all protocols to Lead Clinical Data Managers, Clinical Data Managers, and/or Data Entry staff along with external vendors.
Contribute to the development and/or vision of Clinical Data Management SOPs and related documentation.
Assist in establishing metrics for project progress performance, and cost. Assist in evaluating project performance to these standards.
Serve as primary point of contact for all Client Company project timeline communication.
Assist with resource planning and forecasting.
Maintain awareness of team members PTO requests, ensuring all deliverables will be maintained.
Contribute to Annual Employee Performance Evaluations.
Evaluate and manage project budget against project milestones to ensure project profitability. Take corrective measures where necessary to keep project in line with budgets and profitability.
Conduct internal and external team meetings.
Assist Supervisor with interview and selection process of new staff.
Work closely with CDM Proposals, Operations, Medical Affairs, Strategic Alliances, Strategic Development, Strategic Operations and Information Services Departments to perform appropriate client, indication and therapeutic area research to support the proposal development and required study change orders.
Oversee study eCRFs, IVRS and eDiary implementation projects.
Help utilize and oversee global Data Management Outsourcing and Contracting Projects, Initiatives and Timelines.
Develop relationships with CROs and oversee projects and maintain deliverable.
Oversee Data Management tasks to deliver all milestones with external vendors.
Facilitate the translation of documents such as patient diaries, participation cards, etc. with external translation vendors.
Provide input to new processes and help train new and existing staff members.
November 2010 - February 2012
Senior Clinical Data Manager PharmaNet/i3, Decentralized, PA, US
Review Protocols for accuracy. Review Case Report Forms (CRF) along with eCRFs (Electronic Case Report Forms) as part of preparations for Study Start-Up in the INFORM EDC system.
Build study sites / investigator relationships in the database and create patient blocks. Assign investigators to patient blocks. May attend and present at the investigator meeting. Oversee handling and resolution of all data discrepancies. Assure accurate DCF content and resolutions from clinical sites, re-querying if necessary. Monitor resolutions of data entry items from workflow problem queue. Review vendor data load.
Complete periodic review and quality review of data using the Data Review Plan and tools used to perform quality check. Review data reports and listings for appropriate handling and outliers or potential trends of clinical importance. Accountable for database lock. Verify all data is in the database, all DCFs are returned and validations are resolved through Pune editors. Review and address all CDR (Clinical Data Report) issues. Freeze the database and unfreeze, if necessary, for data modifications.
Represent PharmaNet/i3 on assigned clinical teams. Primary contact for Clinical and CTM. Maintain primary responsibility to ensure successful management and completion for CDM portion of the study. Responsible for follow-up of any CDM related issues from the Study Team.
Ability to multi-task.
Independently maintain appropriate documentation as required by SOPs. Perform project management activities, including tracking of database design and build completion. Assist in routine operations of data management activities for assigned studies such as clinical team interactions / client support, promoting smooth function of CDM shared services, tracking progress to meet milestones, forecasting resource needs.
Responsible for metrics reporting and workload forecasting for all assigned therapeutic area studies. May supervise and mentor staff in routine operations of data management activities.
Participate in review processes including, Safety Review and the Quality Control process for labs. Identify and communicate outstanding critical DCFs. Review DCF responses and update database and/or discrepancy toolset.
Assist in the identification/resolution of production errors and additions.
Design DataFlow Diagrams along with Clinical Data Reports and Data Quality Development Plans.
Help Train and manage globally located staff.
Assist in audits and submission activities for ongoing studies.
Travel to sites or Investigator Meeting when needed.
Serve as a liaison between different departments on a Study Team.
February 2007 - November 2010
Specialist - Clinical Data Project Manager ACCENTURE, Collegeville, PA, US
Review Protocols for accuracy. Review Case Report Forms (CRF) along with eCRFs (Electronic Case Report Forms) using Oracle EDC and RAVE as part of preparations for the Analysis and Database Design (ADD) meetings. Create data validation specification and design documents. Ensure consistency in data handling for therapeutic area. Set up Workflow Admin. Attend and contribute to ADD meetings.
Build study sites / investigator relationships in the database and create patient blocks. Assign investigators to patient blocks. May attend and present at the investigator meeting. Oversee handling and resolution of all data discrepancies. Assure accurate DCF content and resolutions from clinical sites, re-querying if necessary. Monitor resolutions of data entry items from workflow problem queue. Review vendor data load.
Complete periodic review and quality review of data using the Data Review Plan and tools used to perform quality check. Review data reports and listings for appropriate handling and outliers or potential trends of clinical importance. Ensure batch validation and CIDER refresh have been executed successfully.
Accountable for soft lock and database lock. Verify all data is in the database, all DCFs are returned and validations are resolved through Bangalore editors. Review and address all CDR (Clinical Data Report) issues. Freeze the database and unfreeze, if necessary, for data modifications.
Represent ACE on assigned clinical teams. Primary contact for Clinical and CTM. Maintain primary responsibility to ensure successful management and completion for CDM portion of the study. Responsible for follow-up of any CDM related issues from the Study Team.
Ability to multi-task by having the current responsibility to manage over fifteen projects.
Independently maintain appropriate documentation as required by SOPs. Perform project management activities, including tracking of database design and build completion. Assist in routine operations of data management activities for assigned studies such as clinical team interactions / client support, promoting smooth function of CDM shared services, tracking progress to meet milestones, forecasting resource needs.
Responsible for metrics reporting and workload forecasting for all assigned therapeutic area studies. May supervise and mentor staff in routine operations of data management activities.
Participate in review processes including Safety Review and the Quality Control process for labs. Identify and communicate outstanding critical DCFs. Review DCF/SDCF responses and update database and/or discrepancy toolset.
Assist in the identification/resolution of production errors. May assist in resolving issues with workflow admin. Participate in discussion of the development of new objects based on study requirements.
Work with therapeutic area managers to promote consistent operations, efficient use of resources, and sharing knowledge / best practices. Support management of CDM shared services in achieving common goals. Promote teamwork across therapeutic areas. Find common ground, communicate and proactively share information amongst therapeutic team.
May serve on teams to optimize processes and use of CDM related technology to build a more efficient organization. Encourage practical applications of new ideas.
Maintain awareness of developments in technology external to ACE in order to provide input to continuous improvement efforts.
Provide Training support as a Study Matter Expert (SME) on several applications with 10 years' experience with Oracle Clinical and many other applications.
Travel to Clinical Sites to actively support the Client in reviewing patient charts and to collect subject data.
Plan, communicate, drive and track CDM study activities to meet client timelines, milestones and agreed upon SLAs.
Actively provide CDM status updates to study teams, addressing any team CDM-related concerns with ACE editing personnel to drive completion of activities for designated patient groups.
Serve on Capability teams to improve processes and to set/revise standards.
Follow all SOPs/SPIs from study start to database lock and freeze.
Assist in activities for submission studies and audits.
Mentor on and offshore personnel.
Recognized as a People Developer through the Accenture Employee Satisfaction Survey
February 2005 - February 2007
Specialist - Clinical Data Project Manager/Data Management Liaison ACCENTURE, Collegeville, PA, United States
Manage and control access to studies in Oracle Clinical. Build study sites/investigator relationships in the data.
Create patient blocks and assign to investigators.
Review protocols and eCRFs for the Oracle EDC and RAVE databases as part of meeting preparation and electronic database review.
Ensure consistency in data handling for therapeutic areas and batch validation and refresh have been executed successfully.
Review vendor electronic data load; monitor resolutions of data entry items from workflow problem queue.
Perform project management activities, including tracking of database design and build completion.
Promote teamwork across therapeutic areas by sharing information and communicating proactively.
Supervise and mentor staff in routine operations of data management activities conducted both on and offshore.
May 2001 - February 2005
Clinical Data Coordinator ICON Clinical Research Inc., North Wales, PA, US
Responsible for the review and validation of clinical trial data.
Develop, review and test data validation specifications and input.
Ensure adherence to SOPs, clinical study guidelines and FDA regulations.
Support training new staff.
Responsible for writing study specific procedures and edit checks in order to maintain a flawless database.
Perform manual audits of study documentation to ensure sponsor requirements are followed.
Coordinate with sponsor to ensure specific study timelines and deliverables are adhered to as required.
Successfully work between various sponsor databases utilizing multiple data management systems including Oracle.
Assist in testing clinical databases for new clinical studies. Query generation and resolution while working in the eCRF environment.
Review adverse event reporting, study files and data submissions for quality assurance.
EDUCATION
May 1995
Bachelor of Arts Criminal Justice
Allentown College of St. Francis De Sales
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TIMOTHY PAPP
Contact this candidate