Timothy Papp

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.

• 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

• 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

• IQVIA US, Associate Clinical Data Management Director, 2023-04-01, 2025-11-01, 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 improvement 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
• TFS Health Science, Princeton, US, Director, Clinical Data Management, 2022-06-01, Present, Oversees 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, Ensures proper training and development of staff, Conducts 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, Adheres 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
• Statistics and Data Corporation, Tempe, AZ, Manager, Clinical Data Management, 2020-10-01, 2022-06-01, Oversees 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, Provides direction to staff when issues arise that the staff cannot resolve on their own, Ensures proper training and development of staff, Conducts 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, Adheres 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
• PAREXEL International, Decentralized, PA, Senior Data Management Lead, 2019-08-01, 2020-10-01, 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 on 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.
• DOCS Global Inc. / ICON, Decentralized, PA, Data Management Project Lead/Clinical Data Management Manager, 2018-06-01, 2019-07-01, 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 the 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
• PPD, Decentralized, PA, Principal Clinical Data Manager / Manager, Data Management, 2014-11-01, 2018-06-01, 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.
• PRA, Blue Bell, PA, Trial Manager/PDM — Project Data Manager, 2012-02-01, 2014-11-01, 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.
• PharmaNet/i3, Decentralized, PA, Senior Clinical Data Manager, 2010-11-01, 2012-02-01, 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.
• ACCENTURE, Collegeville, PA United States, Specialist - Clinical Data Project Manager, 2007-02-01, 2010-11-01, 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 including: ADD meetings, data validation conducted onshore or in Bangalore, clinical team interactions / client support, promoting smooth function of CDM., 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 Global Survey
• ACCENTURE, Collegeville, PA United States, Specialist - Clinical Data Project Manager/Data Management Liaison, 2005-02-01, 2007-02-01, 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.
• ICON Clinical Research Inc., North Wales, PA United States, Clinical Data Coordinator, 2001-05-01, 2005-02-01, 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.
• GlaxoSmithKline (Volt Subcontractor), North Wales, PA United States, CRF Tracking and Imaging Assistant, Document Management, 2000-10-01, 2001-05-01, Responsible for tracking and processing all Case Report Forms (CRF) and related documentation within CRAMS an Oracle-based tracking system as well as ensuring FDA compliance., Interact with various overseas offices related to CRFs. Perform quality control reviews to ensure quality and completeness of documentation., Maintain productivity statistics as required. Act as customer interface for various requests., Conduct database searches as necessary to complete management and customer requests.
• Sunnybrook Beverage & Entertainment, Inc., Pottstown, PA United States, Operations/Event Coordinator, 1998-01-01, 2000-08-01, Performed consultant activities for banquet preparation to include cost analysis in relation to clientele budgets, ensuring customer satisfaction and managing overall staff event coordination., Responsible for overall design and implementation of floor plans for all events, complete revisions for changing priorities per clientele requests., Manage staff of 30 employees for outdoor events and facilities management. Interact with local and regional business associates for Public Relations in support of Corporate Products.
• Excalibur Security and Investigations, Myrtle Beach, SC United States, Investigator/Security Officer, 1996-01-01, 1998-01-01, Interacted with Human Resources Departments, Business and Resort Managers to assess investigation requirements., Conducted internal undercover surveillance to provide further grounds for employee theft investigations., Accompanied celebrities to various public events to administer armed personal security., Assisted local police authorities to encompass investigation activities of various suspects, provided documented evidence, and assisted in serving both arrest and civil warrants., Interviewed employee fraud suspects, provided documentation to further support investigation activities., Responsible for daily documentation and procedural reports.