Daniel Caffrey Email & Phone Number

Us

• Works with multi-functional teams (internal and external) to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.• Tracks effective and expiration dates of external documents (e.g., clinical laboratory certifications, Medical Licenses, and curriculum vitae [CVs]).• Collects, reviews, and indexes essential documents in accordance with TMF structure.• Uploads TMF documents into the eDMS and/or other document files, e.g. as “working documents” while the study is ongoing.• Acts as TMF Subject Matter (SME) and point-of-contact for study teams and TMF stakeholders.• Provides oversight of Contract Research Organization (CRO)/Vendors when TMF is outsourced.• Provides support and TMF guidance during audit and/or inspections.• Performs other tasks and assignments as needed and specified by management.

Basel, Baselstadt, Ch

QC of Alcon legacy RDDCM and EZViewer for data migration into Novartis CREDI databaseSingle Point of Contact to the Therapeutic Areas (TA)/Clinical Trial Team for TMF related questions and serves as Subject Matter Expert on TMF Quality Control Maintain documentation of appropriate oversight of all external partner’s work specific to document management within the TMF Responsible for optimizing, maintaining, and rolling out TMF Quality Control training mechanisms Translate trial information, processes and regulations into TMF documentation Track progress to key quality indicators (KQIs)s, and overall compliance to TMF processes and regulations Oversight of TMF QC Specialists and monitor QC performed by the TMF QC specialists on assigned trials Provide training/mentoring to the TMF QC Specialists on TMF processes, reconciliation/QC Maintain documentation of appropriate oversight of Vendor TMF Technical Quality Control Personnel specific to document management QC within the TMF Single Point of Contact to the CTT for their assigned trials Provide CTT with TMF QC reports and assist with TMF related questions (e.g. TMF Table Of Content) Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutions Proactively “pull” information during the set-up, execution, and close-out phases from accountable CTT members. Participate in CTT meetings as needed, responsible for the training of CTTs on TMF and implementation of best practices within CTTs Monitor the CTT compliance with TMF process within a trial in a timely manner Participate and/or may lead some meetings related to TMF processes and trainings (e.g. TMF QC Compliance Review Meeting). As a TMF QC group representative, may participate in global cross-functional business process performance or clinical development improvement initiatives. Participate in the on-boarding, mentoring and training of new staff.

Basking Ridge, Nj, Us

Develop Quality Management Trial Master File Quality Control Excel spreadsheet for pilot QM process. Provide recommendations to incorporate specific TMF data as part of QC process.Collaborate with vice-president, global head, associate directors, and consultants to provide QC process and results.Act as subject matter expert and provide training to fellow consultants.

Raleigh, North Carolina, Us

Set up, maintain and review essential documents for the Trial Master File (TMF) including Core Project File (CPF) and Investigator Site File (ISF) of four client studies.Assign ISF and CPF sections for document inventory of TMF protocols to staff including Clinical Trial Associates, Project Coordinators, TMF Associate Contractors and Study Start-Up Unit Specialists.Resolve client issues, questions, and requests for additional study supplies for protocols.Review investigator and project files to verify TMF completeness and accuracy.Train (Sr.) Clinical Trial Assistant(s), (Sr.) Project Coordinator(s), TMF Associate Contractors, Study Start-Up Unit Specialists on sponsor inventory and QC of ISF and CPF Trial Master Files.Delegate QC of ISF & CPF inventory to General Medicine - Project Coordinators, Neuroscience - TMF Associate Contractors and Study Start-Up Unit Members regarding TMF Remediation of four client protocols. QC work received after completion and update Master CPF and ISF inventory QC trackers.Meet with client/contractor to collaborate on ISF and CPF project issues and requirements.Address questions from inVentiv staff, inVentiv management and client.Prepare study project TMFs for client audit.Provide reports to management regarding ISF and CPF remediation progress.Edit TMF Management Plan.

Reviewed electronic and paper trial master file transmittals for inaccurate document types and sub-types and authorized corrections for scan, index and index QC functions.Informed data management, monitors, clinical research associates and clinical services associates of changes to transmittal document types and of corrected file index incompatibilities related to transmittal and document submissions. Provided paper Trial Master File essential documents, Case Report Forms (CRF) and Data Clarification Forms (DCF) for study audits.Prepared and designated file classifications of clinical trials general, investigator and country essential documents within the Archiving and Records Management System (ARMS).Performed quality control of archived materials.Finalized electronic workflow of electronic Trial Master Files (eTMF) document storage as part of Celect 2.0.Maintained paper and eTMF documents while providing scan, index and index QC functions with InputAccel and Adobe Standard 7.0 software.Informed data and project management of computer system needs and information technology issues in conjunction with coordinating the information technology department’s vendor software problem resolutions.

Provided Global Pharmacovigilance adverse event reconciliation and electronic data management.Performed quality control audit for clinical documents as needed. Coded documents for Electronic Trial Master File (eTMF) batching.Indexed essential clinical trial documents into Oracle based Clinical Data Indexing and Tracking System (CDITS) database.Maintained Schering-Plough legacy eTMF and prepared for operation of new Merck Integrated Document Architecture and Services (MIDAS) TMF system with FirstDoc regulatory compliance application for 21 Code of Federal Regulations (CFR) Part 11.Developed work practice instructional summaries for batching, indexing, document return actions, and batch retrieval requests.Redacted documents of classified information to ensure patient confidentiality.Prepared Crystal Reports, researched data duplicates and prepared document summaries for clinical trial team.

Responsible for ensuring project deliverables are met for Pfizer.Maintained quality guidelines with established metrics related to 100% quality control (QC) supervision.Performed eTMF review and QC activities using sponsor legacy documentum system and prepare data for transfer to new EDMS.Located eTMF documents, review indexing errors and note discrepancies on excel inventory sheet with hypertext document copy transfer.Maintained the Essential Document List to determine document applicability for each study.Performed relational QC for documents as needed. Identified missing documents with review of legacy documentum and data transfer to current EDMS. Performed supervisory QC of reviewers data transfer accuracy of protocol, drug, and site level documents with randomized 5% sample and 100% re-review and re-route with error identification and document location as needed.

Established guidelines with project managers, clinical trial managers and clinical research associates (CRA) regarding electronic and paper TMF study start-ups, study closures, data queries, SAE reports, ad hoc requests, file maintenance, study archiving and sponsor shipments.Managed inventory shipping and developed packing lists for document transfers while meeting 100% of shipment deadlines.Performed scanning, indexing and quality control for electronic TMF with 35% increased accuracy.Prepared transmittal error logs related to electronic and paper TMF and notified Manager and CRA..Improved management and employee communications 700% with in person discussion and team solutions.Provided agenda for Central Files Staff Meetings and discussed key points regarding standard operating procedures (SOP) and work practices.Nominated for Operational Excellence Award due to quality control expertise for two consecutive years. This award encompasses all of the companies within the United Health Group family.Supervised and instructed team members on specific protocol SOP and filing criteria.

Corresponded with field monitors on case report forms (CRF), data query forms (DQF), and transmittal reports.Responsible for receipt and transport of project study files. Supervised the in-house filing of CRF, DQF, and transmittal reports.Validated accuracy of mail received with CRF Transmittal Reports and noted on discrepancies report.Quality controlled files for MDRC, Medical Documents, and Data Management Departments.Archived 100% of locked database files.

Data analyzed report accuracy of developer 1 output with developer 2 output.Noted output inconsistencies and informed project managers, developers and verifiers.Met with project managers, developers and verifiers to provide and establish project priorities.Maintained 100% of in-house training administration of employees and consultants with report presentation and in person follow up.Updated filing (electronic and paper documents) of MS Excel records to support in-house and FDA audits.Provided Global Information Technology (GIT) with department training records.Assisted manager with special projects including ad-hoc request logs and presentation binders.

Led processing of vendor ophthalmic rebates into Access database.Met with Rebate Project Team and developed SOPs, identified data inconsistencies, and coordinated query resolution.Provided quality assurance of rebate record entries and pharmaceutical rebate reports.Assisted database design development.Created filing (electronic and paper documents) system of entered records to support auditing functions.

Performed data entry of critical data from case report forms (CRF) for clinical research studies in the pharmaceutical and biotech industries.Performed quality assurance with double-key verification and data analysis.Developed data entry guidelines and procedures.Participated in quality control and database audit functions at the completion of studies.Assisted with the validation of data entry screens and database design.Assisted Management Information Systems (MIS) Department with printer maintenance.