Andrew J. Seeran
Drexel Hill,PA
Summary
Proven leader in Quality Assurance and Compliance Auditing, I leveraged expertise in Veeva and CTMS to enhance audit readiness and risk management at Labcorp, driving significant improvements in audit preparation and response processes. Skilled in team training and project management, I excel in high-stakes environments, ensuring excellence and efficiency.
Overview
9
9
years of professional experience
Work History
Family Leave
-
11.2024 - 11.2024
- Personal leave to support family
GCP Auditor (Sr. QA Compliance Auditor)
Labcorp
Indianapolis, IN
02.2023 - 11.2023
- Company Overview: Contract: Planet Pharma
- Lead functional groups in audit preparation, scheduling, provision of responses and post-audit follow-up for a CAP, CLIA and GCP regulated Central Laboratory that hosts 70 audits a year and processes thousands of samples daily
- Assessed and managed risk throughout audit process, factoring in client relationship, project history and key opinion leaders to anticipate challenges, preempt conflict and limit misunderstanding/miscommunication
- Scheduled and organized scope and agenda with auditor, for facility tour and presentation sessions
- Provided requested policies, SOPs, WIs and any other controlled or supporting documents, utilizing Veeva Quality Documents and secured file share portal
- Lead process owners to assign and assure correctness, timeliness and tone of responses to audit findings and client inquiry using Veeva QMS
- Performed internal audits according to global internal audit program, interviewing process owners, performing training review and writing reports
- Global Lead for 2023 Q3 internal audit responsible for developing scope, audit agenda, assignment and severity of findings according to Quality Management System
- Contract: Planet Pharma
GCP Auditor (Risk Manager)
Meridian Clinical Research
Omaha, NE
03.2022 - 10.2022
- Worked to build new department, under direction of VP and senior Risk Manager, for audit and inspection readiness within a network of thirty three (and growing) clinical research sites
- Trained and oriented growing team to organizational structure, existing software platforms within developing departmental role, responsibilities and priorities
- Performed in-person audits, reviewing ICFs, ISF, subject charts, CRFs, pharmacy and lab binders, as well as interviewing staff to identify deficiencies and risks
- Mediated sponsor and monitor escalations and aids sites in resolution of CAPAs, PIPs and quality issues providing additional education, training, relationship management and project management
- Developed Sharepoint platform to integrate reporting, identify trends and create metrics for business intelligence and resource planning
Project Manager (Pharmacoepidemiology Coordinator)
Eli Lilly and Company
Indianapolis, IN
05.2021 - 03.2022
- Company Overview: Contract: Medasource
- Provided project management support within Global Patient Safety, pharmacoepidemiology division, to meet safety commitments in US, EU and Japan
- Reviewed contracts for budget and scope changes, deliverables and pass-through costs
- Secured project alignment between internal partners in medical, regulatory, data management and marketing to ensure appropriate scope, timing and resourcing of post-market studies
- Supported epidemiologists in vendor selection, qualification, oversight and escalations
- Maintained line-of-sight across compound/product portfolio to eliminate frictions among parallel projects and leverage insights
- Developed and lead workstreams to identify operational challenges, develop action plans, update procedure and gain buy-in from leadership
- Used Veeva Quality Docs and Veeva RIM for controlled document management
- Contract: Medasource
Clinical Research Coordinator (Remote Research Assistant)
IQVIA
Durham, NC
09.2020 - 05.2021
- Company Overview: Contract: Aerotek
- Supported portfolio of Phase I/II/III COVID-19/SARS-CoV-2 studies with novel decentralized trial design
- Met weekly with constellation of high-enrolling sites to determine need for and provide data and operational support according to dynamic scope of work
- Reviewed CRFs, lab results and requisition forms for consistency with EDC and patient contact documentation system
- Provided ongoing updates of review status to sponsor, setting targets according to planned data locks
- Contract: Aerotek
Clinical Data Coordinator
IU Simon Cancer Center
Indianapolis, IN
02.2019 - 06.2020
- Company Overview: Contract: PMG Research
- Supported Phase III, high risk, oncology trial for post-bone marrow transplant subjects developing chronic Graft-versus-Host Disease
- Back reviewed patient records for consistency with EDC and escalating concerns to site monitors, medical monitor and where necessary scheduling calls with sponsor or trial manager
- Entered data from paper and electronic sources into Bioclinica-based CRFs (Case Report Forms)
- Worked closely with site monitors, data management and clinicians to identify and correct errors in source documents and CRFs
- Tracked and reconciled updates to paper source, CRFs and EMR/EHR to assure GDP is being followed
- Provided guidance and clarification to clinical research nurses and investigators as indicated by study sponsor and trial team
- Contract: PMG Research
Data Manager (Device Registry Project Coordinator)
Watermark Research Partners
Indianapolis, IN
05.2017 - 02.2019
- Operations and Data Management for Phase IV/post-market surveillance for major medical device companies
- Managed sites from start-up through execution: initial contact, contracts, data transfer agreements, IRB submission status, site training and ongoing education
- Tracked site re-imbursement and invoicing for sponsor compensated activities
- Provided site readiness, start-up and enrollment metrics to sponsor
- Managed data queries, cleaning and resolution
- Authored CRFs, data dictionaries, user manuals for EDC
- Performed functional testing, export testing and statistical export mapping
Clinical Trial Associate (Clinical Trial Project Management Assistant)
Eli Lilly and Company
Indianapolis, IN
09.2015 - 04.2017
- Company Overview: Contract: Kelly Services
- Supported Early Phase oncology clinical trials with trial teams and site participation spanning North America, Europe and Asia
- Provided status updates for on-going projects to team members and superiors
- Scheduled and took minutes for trial team meetings
- Followed up on 'action items'
- Setup printing of medical and informational materials for studies
- Tracked study timelines and inventory with country managers to ensure material delivery in time for medical trainings and patient enrollments
- Performed full review of Trial Master Files and handled migrations to Veeva eTMF
- Contract: Kelly Services
Education
M.S. - Data Science
Johns Hopkins University
Baltimore, MD01-2027
B.A. - Neuroscience
Franklin College
Franklin, INSkills
- Quality Assurance
- Compliance Auditing
- Testing
- Veeva (Quality Docs, eTMF, RIM, QMS)
- Oncore
- Workday
- Trackwise
- CTMS (IMPACT, Clinical Conductor, Study Hub)
- LMS
- Jira
- Various Proprietary 21CFR11 systems
Timeline
Family Leave
-
11.2024 - 11.2024
GCP Auditor (Sr. QA Compliance Auditor)
Labcorp
02.2023 - 11.2023
GCP Auditor (Risk Manager)
Meridian Clinical Research
03.2022 - 10.2022
Project Manager (Pharmacoepidemiology Coordinator)
Eli Lilly and Company
05.2021 - 03.2022
Clinical Research Coordinator (Remote Research Assistant)
IQVIA
09.2020 - 05.2021
Clinical Data Coordinator
IU Simon Cancer Center
02.2019 - 06.2020
Data Manager (Device Registry Project Coordinator)
Watermark Research Partners
05.2017 - 02.2019
Clinical Trial Associate (Clinical Trial Project Management Assistant)
Eli Lilly and Company
09.2015 - 04.2017
M.S. - Data Science
Johns Hopkins University
B.A. - Neuroscience
Franklin College