Thomas Bolger

Experience

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  Microbiology Quality Control Laboratory

  Jun 2007 - Sept 2007

  Laboratory Technician

  Responsible for acquiring primal and offal samples and testing for entero bacteria. Bacteria, e coli 0157 and total viable count. Ensuring lab remained fully supplied at all times.Preparing agar and nutrient brothPerform audits for hygiene

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  Virology Diagnostic Unit

  Jun 2010 - Sept 2010

  Laboratory Technician

  Record temperature logs for freezers, fridges and incubatorsAliquot samplesRegistration of samplesHomogenise post mortem samplesGrow cell linesEnsure laboratory remained stocked at all timesSterilise and dispose of well platesPrepare various reagents and mediaCalibrate scalesClerical responsibilities

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  Quintiles

  Oct 2011 - Dec 2013

  Associate Clinical Data Coordinator

  Maintain, update and clean clinical database to ICH-GCP standard. Maintain study documentation in preparation of internal/external audits.Perform QC audits of clinical database (Inform/Oracle/Fortis)Reconciliation of external vendor dataPoint of contact for vendors and clinical sites attempting to resolve data management issuesPrepare projects for auditsPerform comprehensive data reviewPerform data transfersGeneration of reports

• 

  PAREXEL

  Jun 2014 - Jan 2015

  Senior Clinical Data Analyst (Contractor)

  Maintain, update, validate and clean clinical trial data to ICH-GCP standard. Review and resolve any issues that arise via Sponsor feedback.Generation of reports.Perform quality control of transfer data.Train new team members on study tasks.Coordinate a team of four people in completion of complex Data Management tasks.

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  UBC

  Jul 2015 - Oct 2018

  • Responsible for all aspects of Site Management and Monitoring of clinical studies from initiation through close out, remote monitoring, completion of visit reports and tracking in CTMS and other systems within requested timelines.• Involvement in Feasibilities and start up of studies assigned.• Preparation of study documents and support in submissions.• Assist in the preparation of study specific procedures and guidelines.• Working with a local and international project teams.• Perform source data verification of site data• Assist sites with data query resolution.• Review and maintenance of regulatory documents as per study and local requirements.• Liaise between the sites and project teams and establish good communication and relationship. Show less • Responsible for all aspects of Site Management and Monitoring of clinical studies from initiation through close out, remote monitoring, completion of visit reports and tracking in CTMS and other systems within requested timelines.• Involvement in Feasibilities and start up of studies assigned.• Preparation of study documents and support in submissions.• Assist in the preparation of study specific procedures and guidelines.• Working with a local and international project teams.• Perform source data verification of site data• Assist sites with data query resolution.• Review and maintenance of regulatory documents as per study and local requirements.• Liaise between the sites and project teams and establish good communication and relationship. Show less Contact potential investigator sites in accordance with the project specific feasibility process to determine site interestAssure timely entry of feasibility results in Clinical Trial Management System (CTMS) and/or applicable tracking mechanism (e.g. supporting Excel file(s)Call to recruit prospective investigator sites in accordance with the project specific recruitment plan. Resolve any missing or incomplete entries within CTMSPrepare and forward regulatory document packets and simplified site contracts to investigators Receive and review/process completed regulatory documents and completed simplified site contracts from investigators and forward to the Regulatory Document Specialist (RDS) for final reviewEnsure timely entry of site contact and status of regulatory documents and simplified contracts in CTMS or other project specific tracking databases.Contact the site regarding any follow up issues that are identified by the RDS and update CTMS accordinglyContact with the investigator sites via i.e., phone, written, email, or otherwise as outlined in the protocol or other project guidance documentsReceive and review Data Collection Tools (case report forms) for completeness, accuracy, and legibility and for possible Serious Adverse Events (SAEs) that may have been recordedProvide site management activities for assigned sites that may include, but are not limited to:•Proactive contact of sites to discuss study progress•Track subject enrollment status•Track subject adherence to study visit schedule•Resolve queries with sites•Track drug/study supply inventory and process resupply•Process investigator payments•Inquire regarding potential SAEs that may not have been previously reported•Address/follow up with any questions or issues•Attend study team teleconferences and provide updates, as necessary•Conduct specific monitoring visit phone calls and complete the requisite trip reports according to established guidelines per Sponsor approval Show less

  • Clinical Research Associate

    Aug 2017 - Oct 2018

  • Acting Clinical Research Associate

    Jun 2016 - Jul 2017

  • Clinical Site Specialist

    Jul 2015 - Jul 2017
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  ICON plc

  Oct 2018 - Feb 2021

  Clinical Research Associate II
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  Clintec

  Feb 2021 - Jan 2022

  Senior Clinical Research Associate outsourced to MSD
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  Parexel

  Jan 2022 - now

  • Associate Clinical Trial Manager

    May 2023 - now

  • Associate Clinical Operations Leader

    Jan 2022 - Apr 2023