Daniel Peel Email & Phone Number

Wilmington, Delaware, Us

• Assisted in the creation of Incyte’s TMF Pilot Program• Created a TMF management plan to allow for a large number of TMFs to be incorporated into the Incyte while maintaining audit-readiness at all times with limited resources• QCed high volumes of TMF documents in a way that automatically created individualized retraining programs for uploaders • Created a lean six sigma based formula which allows corporations to convert time savings from process improvement into monetized units• Completed multiple UAT testings• Completed updates within iCore and InForm repositories• Discovered or crafted creative workarounds for difficult situations• Explained the roles and responsibilities of the CTS function to new hires in a public setting• Conducted QCs of CRO TMFs• Conducted multiple 100% QCs of both CRO and in-house TMFs.• Liaised with CTMs, COLs, and CROs to collect, organize, and approve site information• QCed regulatory information across various repositories• Assisted trial teams with vendor communications

Basking Ridge, Nj, Us

• Performed comprehensive QC of post-database lockout early phase trials• Capable of thoroughly quality checking 400+ documents per days while catching any and all discrepancies• Experienced in identifying and fixing trends throughout incorrect clinical data sets• Organized, uploaded, and cleared outstanding data backlog• Managed third-party TMF-related tasks• Coordinated functional TMF close-out processes with clinical team• Assisted with TMF migration from DSfD to Veeva Vault

Ensures adherence to SOPs and GCP requirementsAssists Biogen Site Monitoring Specialist Team with managing and trending performing site monitoring oversight tasks, including CRO Monitoring Report Review and monitoring output document review to identify risksManages and coordinates SharePoint sites to facilitate information sharing and stakeholder communicationMaintains a library of site-focused patient communicationsSupports site monitoring partnership team with creating processes, supporting process improvement initiatives and attending key meetings for optimizing site management activitiesCreated an excel library to track and categorize COL notifications over the lifetime of all active drugs in Biogen’s pipelineEstablish a tracking system to flag site risks at regulatory, regional, and operational levelsExperience in identifying broad based issues and writing affiliated CAPAs

Sydney, Nsw, Au

Performed investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, maintenance tasks, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, SOPs, ICH/GCP guidelines and all applicable regulatory requirementsUtilized the TMF to ensure investigator recruitment activities are accurately trackedSupported investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and IRB/IEC requirementsPerformed study tracking via TMF or Sponsor designated system to ensure that the study files are current, accurate and complete Assisted with resolution of investigational site/data queriesLiaised with project team members regarding study site issuesProvided quality review of the informed consent templateActed as a liaison with clinical supply/service vendors and other functional area team members tomeet project team goalsIdentified monitors, documents, and tracks out-of-scope activitiesAssisted with Investigational Product accountability and subject screening/enrollment.Served as an Independent Essential Document Reviewer of Essential DocumentsAssisted in the creation and maintenance of clinical project documents including, but not limited to CMPs, monitoring Guidelines, and SOMs under the guidance of the SUL/CTMInteracted with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions

Reconciled queries between various regulatory, sponsor, and vendor documentsParticipated in the start-up of Phase I gout, Phase I Bococizumab manufacturer comparison, Phase IV pediatric venous thromboembolism, and Phase I obese diabetes studiesCreated multi-function trackers for team useCompleted tasks accurately on scheduleProvided routine and ongoing maintenance for the TMFPrepared regulatory Investigator Site Master File and Pharmacy Binders prior to SIVEdited regulatory manuals for TMF complianceReorganized lab results for improved readability by site physiciansInvestigated and resolved enrollment discrepancies between sponsor repositoriesCompiled SUSAR reports for circulation within the study teamAchieved 100% compliance with all internal and sponsor trainingAssisted colleagues with the use of Pfizer systemsProvided minutes for Sponsor and Internal teleconferencesLiaised with project managers, start-up specialists, directors, managers, team leaders, and document and repository owners to ensure deliverables were metEditor of the inVentiv Health Clinical Project Coordinator Newsletter. Also editor of three other newsletters including another corporate newsletter and an academic newsletter which received a national award.

Clinical Trial Reconciliation SpecialistOversaw phase II, III, and IV diabetes trials to lockoutExperienced with both paper and electronic trial master file reconciliation and verificationTracked retrieval of medical devicesWorked with sensitive regulatory documents including but not limited to – Medical Licenses, CVs, 1572s, DMPs, CRFs, Investigator Receipts, Confidentiality Agreements, Study Drug Forms, Monitoring Plans, Site Qualification Visit Reports, Contact Reports, Monitoring Visit Reports, Site Visit Logs, Regulatory Correspondence, IRB Approvals and Approved Documents, and Translation CertificatesIncreased output of regulatory document approval system with one week of usageReconciled eight to nine sites per dayCompleted two reconciliations ahead of trial lockout

King Of Prussia, Pa, Us

Experienced with both oncology and cardiovascular trialsAchieved Wall of Fame Award for supporting hard-copy study close-out activities while onsite in Dallas, Texas as a representative for ExecuPharm to both the client and US OncologyLed a joint-venture trial master file remediation with multiple CROsAssisted with the creation of an internal IRB Expiry and Blind Break Account Tracking Procedure ManualNavigated complex protocol deviation documents with lead clinicians to create comprehensive 16.2.2 formsCreated a multi-repository investigation training tracker in excelManaged clinical, regulatory, and study-related documentsProduced quality deliverables consistently ahead of schedule Developed solid working knowledge of client repositoriesDirected teleconferences with study managers and clinical project managers discussing changes to the new trial master file quarterly data audit process and reviewing each study’s respective quarterly data audit line by lineAuthored an instruction manual for colleagues on how to use and update a recruitment and country start-up tracking spreadsheetProvided routine mentorship for new colleaguesDealt with both US and international sitesAchieved 100% compliance with all client and in-house trainingActed as chairman to the ExecuSafe Committee:Presented monthly safety lectures to office and remote clinical trial assistantsCreated and distributed quarterly safety newsletterCoordinated communications with centralized groups, study managers, and outside vendors to ensure study deliverables were met

Set up a new office within the Philadelphia ShipyardFacilitated supplier network meetingsWorked directly under the CEO

Marketed and tested vintage audio equipment and spare parts

Won first place at National Junior Classical League Conference in 2000Continued as Pennsylvania Senior Classical League Secretary from 2002 – 2003 and as Pennsylvania Senior Classical League Newsletter Editor from 2003 – 2004

Taught English and Latin to elementary and middle school children

B.A, Anthropology

Lean Six Sigma Certified, Process Improvement