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

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

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.

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.

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.

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.

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.

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