Ian P. Anderson
Union Grove,USA
Summary
Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
14
14
years of professional experience
Work History
Study Project Manager II
AbbVie Inc.
10.2023 - Current
- Management of two enterprise critical Hepatocellular Carcinoma clinical trials
- Strategic planning for study conduct and meeting company deliverables
- Lead cross-functional team to ensure success of study
- Assist in study protocol creation, review, and amendments
- Drive study EDC/IRT/ePRO/Central Lab system creation
- Review of vendor documents, SOWs, and systems
- Processing of vendor and US site invoices
- Management of risk management plans, quality tolerance limits, and key risk indicators
- Creation of protocol training materials and study conduct materials
- Protocol deviation/issue review and processing
- Oncology Diversity Workstream member; led Diversity Playbook creation
- Late Stage CSL representative for End-to-End project plan development pilot and business development opportunities
- EHS Member certified in CPR/AED/First Aid
Study Project Manager I
AbbVie Inc.
08.2021 - 09.2023
- Management of two Enterprise Critical Hepatocellular Carcinoma clinical trials
- Strategic planning for study conduct and company deliverables
- Lead cross-functional team to ensure success of study
- Assist in study protocol creation, review, and amendments
- Drive study EDC/IRT/ePRO/Central Lab system creation
- Review of vendor documents, SOWs, and systems
- Review of vendor and site budgets
- Management of Risk Management Plans and Key Risk Indicators
- Creation of Protocol Training Materials and Study Conduct Materials
- Protocol Deviation/Issue Review and processing
- Initiative participation for Oncology Diversity Strategy
- EHS Member certified in CPR/AED/First Aid
Study Management Associate III
AbbVie Inc.
11.2017 - 08.2021
- Assist in management of a Phase 3 Axial Spondylarthritis clinical trial
- Manage countries/sites in NA, JAPAC, ME, EU
- Track and assist in study start up
- Assist in Protocol creation, review, and amendments
- Assist in study EDC/IRT/ePRO/Lab system creation
- Assist in review of vendor documents, SOWs, and systems
- Management of central lab vendor, wearable device vendor
- Management of Key Risk Indicators
- Creation of Protocol Training Materials and Study Conduct Materials
- Management of IP relabeling/expiry in US and ex-US to completion
- Protocol Deviation/Issue Review and processing
- Assisted in Database Lock and CSR preparation for FDA Submission
- EHS Member certified in CPR/AED/First Aid
- Previously assisted in management of a Phase 3 Giant Cell Arteritis/Immunology and Phase 3 Rheumatoid Arthritis/Immunology clinical trial
Study Management Associate II
AbbVie Inc.
07.2016 - 11.2017
- Assist in management of a Phase 3 Rheumatoid Arthritis/Immunology clinical trial
- Manage sites in US, Israel, and Turkey
- Management of IP relabeling in US and ex-US to completion
- Track and assist in study start up
- Deviation Review and processing
- IVRS System Data Correction Review and processing
- EPRO Questionnaire Data Correction Review and processing
- Assist in Database Lock and CSR preparation for FDA Submission
- Creation of Protocol Training Materials and Study Conduct Materials
- EHS Member certified in CPR/AED/First Aid
Clinical Research Associate II
Quintiles
06.2015 - 07.2016
- Experience monitoring Phase 2 and 3 Oncology studies
- Monitor for Site Monitoring Visits to perform Source Data Verification, IP Accountability, and On-Site Regulatory
- Lead CRA for Phase 3 Study
- Remote SDV and query resolution
- Experience performing Pre-Study Visits, Site Initiation Visits, Site Monitoring Visits, and Site Close-out Visits
- Write confirmation/follow-up letters to sites for monitoring visits
- Overall site management, follow-up, and issue resolution
- Writing monitoring visit reports post visit completion in CTMS
- Submitting expense reports
Clinical Research Associate II
ICON Clinical Research
03.2015 - 05.2015
- Experience monitoring Phase 2 and 3 Oncology studies
- Monitor for Site Monitoring Visits to perform Source Data Verification, IP Accountability, and On-Site Regulatory
- Experience performing Pre-Study Visits, Site Initiation Visits, Site Monitoring Visits, and Site Close-out Visits
- Write confirmation/follow-up letters to sites for monitoring visits
- Overall site management, follow-up, and issue resolution
- Writing monitoring visit reports post visit completion in CTMS
- Submitting expense reports and being responsible for paying bill for corporate credit card
- File regulatory documents to an electronic Trial Master File database
Clinical Research Associate I
ICON Clinical Research
05.2013 - 03.2015
- Experience monitoring Phase 2 and 3 Oncology studies
- Monitor for Site Monitoring Visits to perform Source Data Verification, IP Accountability, and On-Site Regulatory
- Experience performing Pre-Study Visits, Site Initiation Visits, Site Monitoring Visits, and Site Close-out Visits
- Write confirmation/follow-up letters to sites for monitoring visits
- Overall site management, follow-up, and issue resolution
- Writing monitoring visit reports post visit completion in CTMS
- Submitting expense reports and being responsible for paying bill for corporate credit card
- File regulatory documents to an electronic Trial Master File database
Clinical Trial Assistant
ICON Clinical Research
04.2012 - 04.2013
- Meeting minutes to support study teams for 5 different Oncology clinical trials
- Pulling reports from CTMS for 5 trials
- Proficient in trial related database navigation and usage for ICON and Sponsor
- Maintain electronic Trial Master File database, In-house Paper files, and internal drive for all sites on 5 trials
- Ship study supplies to sites
- Diligent site communication regarding document reconciliation, special requests, etc
- Recognized on the Sponsor Business Unit Wall of Fame for my diligent and efficient work ethic
- Support study team reconciliation work for the Director of Clinical Management Team for the entire Sponsor Business Unit
- Participate on the Sponsor Response Team to provide SAE/Safety Report Listings to the Clinical Teams
- Co-monitor for Site Monitoring Visits to assist with On-Site Regulatory and IP Accountability
- Presenting at Sponsor CTA Monthly Teleconference about Safety Reporting
Biologist III
Abbott Laboratories
09.2010 - 04.2012
- Tissue culture and management including wild-type and stably transfected HEK-293, HepG2, and MDCK cells including cell passage and cell plating for all cell-based experiments for the department
- Performed cell-based screening assay for inhibition and IC50 determinations of 6 different drug transporters
- Completed cell density and cellular protein determination for a SimCyp collaboration
- Method development and implementation for optimizing the cell-based assay for transporter inhibition by use of fluorescent substrates
- Presented results of fluorescence method development to Drug Metabolism Department and the presentation was well delivered and received
- Acquired techniques for the use and maintenance of a fluorescence microscope
- Tested and optimized the functionality of a cell culture performing robot
- Performed back-up duties for a Tailored Tier-1 PXR-AHR Induction Assay
- Received a Bronze award, usually only reserved to fulltime employees, for my continued support of the High-Throughput ADME group
Education
Master of Science - Applied Biotechnology
University of Wisconsin-Parkside
Kenosha, WI12.2022
Bachelor of Science - Molecular and Cellular Biology
University of Illinois At Urbana-Champaign
Urbana-Champaign, IL05.2010
Skills
- Project management
- Project planning and development
- Strategic planning
- Team collaboration
- Critical design review
- Risk Management
Volunteer Experience
- Racine Theatre Guild, Vice President of Membership, 06/01/13, Present
- Union Grove High School Theatre Department, Costume Designer, 08/01/17, Present
Timeline
Study Project Manager II
AbbVie Inc.
10.2023 - Current
Study Project Manager I
AbbVie Inc.
08.2021 - 09.2023
Study Management Associate III
AbbVie Inc.
11.2017 - 08.2021
Study Management Associate II
AbbVie Inc.
07.2016 - 11.2017
Clinical Research Associate II
Quintiles
06.2015 - 07.2016
Clinical Research Associate II
ICON Clinical Research
03.2015 - 05.2015
Clinical Research Associate I
ICON Clinical Research
05.2013 - 03.2015
Clinical Trial Assistant
ICON Clinical Research
04.2012 - 04.2013
Biologist III
Abbott Laboratories
09.2010 - 04.2012
Master of Science - Applied Biotechnology
University of Wisconsin-Parkside
Bachelor of Science - Molecular and Cellular Biology
University of Illinois At Urbana-Champaign
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