Sean King
Highlands,NJ
Summary
Experienced Systems Administrator with over 15 years experience in design, development and maintenance of clinical systems, including TMF, CTMS, EDC, IRT and others. Highly proficient in implementing enterprise solutions for business applications in broad scale, web-delivered environments. Determined to deliver best technical solutions to meet functional and business requirements. Diligent troubleshooter, with strong communication skills to interact effectively with employees and departments. Flexible with positive work attitude focused on producing results under tight deadlines.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Clinical Systems Administrator
Chinook Therapeutics
2022.06 - 2024.08
- Supported the administration of Trial Master Files (TMF) and/or the Clinical Trial Management System (CTMS) across the Chinook portfolio
- Assisted in development of company SOPs related to TMF Management, Document Processing and Management, Document Archival, Data Transfer of archived and active TMFs, and Clinical Systems and Business Administration
- Collaborated with Study Team(s) to initiate study set up, supports build out, manages systems access, conducts systems training and onboarding
- Created training materials for CTMS/TMF management and trained internal personnel and study team on use
- Provided ongoing support to users throughout the life cycle of the study
- Administered Veeva eTMF and/or CTMS and perform daily system maintenance activities
- Supported management of the full life cycle of TMF/CTMS activities from study initiation, through study execution, closure, to archival, contacts management, document processing, tracking and dashboarding
- Performed routine document quality control per ALCOA+C and any specific company-defined requirements
- Identified issues, risks, and trends (e.g., retraining opportunities) related to systems use
- Provided initial and ongoing training to systems users in a manner highly responsive to trainee needs (department and role) o Be available for ad-hoc, regular and general support to trainees and users
- Partnered with the Manager, Clinical Systems to create and maintain internally controlled documents and other resources/tools related to TMF/CTMS use, e.g., SOPs, work instructions, training materials, and forms
- Carried out system activities as assigned such as change requests, system upgrades, validation testing, and simple customization within the system
- Maintained and supported ongoing development of reports and dashboards, including TMF health and associated KPIs
- When problems arose, helped to determine root causes, and in collaboration with Manager, Clinical Systems and relevant stakeholders, initiate corrective and preventative action as appropriate
- Worked proactively to address business and people needs as well as system-related issues
- Actively increased knowledge, understanding, and expertise in TMF/CTMS management and related global regulations
- Contributed to the development and maintenance of a positive team-focused company culture
Senior Clinical Research Associate
Reistone Biopharma
2021.03 - 2022.06
- System Administrator for sponsor CTMS system, including completing study/protocol set-up, assist in integration of outside vendors, creating report templates, completing and verifying reports, provide troubleshooting assistance for users, developing training materials for system users, add and remove personnel, and provide reporting for milestones, reporting, and compliance
- Completed sponsor submissions to central IRB and granting access to study sites and personnel
- System Administrator for sponsor eTMF, including developing naming conventions and classification documents, uploading, verifying and approving regulatory documentation, creating study sites, study personnel and site locations, creating and editing milestones, developing training aides for study personnel
- And working with vendor to troubleshoot any issues with sponsor team members
- Train sites on study protocols, study procedures, company background and portfolio, and vendor platforms
- To ensure all related clinical research operations and procedures are in compliance with protocol, sponsor’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations
- Perform regulatory, Start-up, and maintenance activities according to applicable regulations, SOPs, and work instruction
- To be responsible for clinical study sites selection and to ensure these sites can meet the sponsor’s requirements and qualified with FDA
- To be responsible for clinical trial start-up at sites, include complete GCP submission, obtain the EC approval, contract negotiation and sign-off
- To be responsible for initiating, monitoring and closing the clinical study sites and submit the visit reports on time
- To be responsible for submitting documents to site GCP office & EC correctly and on time
- To ensure storage, distribution, return IMP/NIMP at the sites and report of deviations in compliance with protocol, sponsor’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations
- To be responsible for using CTMS or required system and trackers in clinical trial and ensure information entered into CTMS or required system and trackers is accurate and updated regularly
- To ensure AEs/SAEs are recorded correctly and reported appropriately according to timeline stipulated in clinical study protocols and current regulation
- To ensure the study sites update and maintain essential documents in Investigator Site Files correctly and on time
- To be responsible for transfer Reistone study essential documents to TMF on time and consist with ISF
- To build and keep good working relationship with clinical study sites
- To be able to complete the above tasks under the help and supervision from senior team members with satisfaction
- Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
- Ensure the quality of the data
- Maintain appropriately and safely all necessary documents in Trial Master Files.
Senior Clinical Research Associate 2
IQVIA, Inc.
2019.01 - 2021.03
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Manage quality and compliance issues for sites
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution and provide support during project/site start-up phase
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Act as a mentor for new clinical staff for clinical staff including conducting co-monitoring and training visits
- May provide assistance with design of study tools, documents and processes
- Convey features and opportunities of study to site
- Collaborate and liaise with study team members for project execution.
Clinical Research Associate
SynCardia Systems LLC
2013.03 - 2019.01
- Provide site management and monitoring services for this manufacturer of the biventricular artificial heart
- Responsible for source document review and verification of case report form data, adverse event identification, monitoring reports and correspondence, essential document management, and oversight of safety and protocol deviation reporting to sponsor and regulatory authorities for all east coast sites.
Clinical Trials Coordinator
Clinical Perspectives LLC
2012.10 - 2016.12
- Review of pre-study site visit reports and evaluations
- Manage essential documents management/study start-up documents
- Review/query Monitoring Reports
- Prepare monitoring reports
- Provide reporting CTMS
- Preparation and management of site and master files
- Preparation and initial review of Clinical Trial Agreements.
Project Manager
Complete Medical Communications
2012.02 - 2012.09
- Manage communication programs for global medical communication company
- Directed program start up meetings, budgets, timelines and metrics for assigned projects
- Coordinated communication with scientific team, production, finance, client services team
- Provided logistics support for business development initiatives
- Worked on database for tracking/planning publications and promotional programs
- Responsible for project phasing and reporting
- Coordinated Publications Specialist Committee meetings
- Trained on Pfizer Datavision, RapidAccess, GDAS, and ECF online systems.
Consultant, Projects/Grants Coordinator
MedCases LLC
2007.05 - 2012.01
- Utilized technical expertise to champion interactive programs on behalf of pharma clients
- Provided on-site meeting support with Audience Response System
- Provided on-site recruitment and meeting planning for live symposia and seminars
- Updated HTML content on www.challengingcases.com and www.medcases.com and all front matter pages on Challenging Cases
- Responsible for converting over 35 case documents into online case simulations
- Consistently exceeded client goals of staying on budget and timelines
- Successfully submit grants using various online systems: Novartis, Genentech, Sanofi-Aventis, Pfizer, Onyx, Bayer Healthcare, Bristol-Myers Squibb, OSI Pharmaceuticals, Daiichi Sankyo, Eli Lilly, Wyeth, Abbott, Boehringer Ingelheim, Cephalon, Celgene.
Consultant, Coordinator
H&H Consulting
2008.07 - 2009.07
- Planned Investigator and other meetings for clinicians and physicians
- Worked with clients to provide all necessary logistics for investigator meetings and studies
- Prepared project materials, including creating Site folders for clinical trials
- Supervised the development of SOPs for clinical research monitoring.
Project Materials Coordinator
Indegene Pharmaceutical Solutions, Inc
2007.01 - 2008.07
- Facilitating the Production Process: Weekly communication with members of the program management team to determine status (Reference Binders, Kickoff Meeting Binders, CDs/DVDs Production, Print Materials, Contracts, Any document or material that needs to be generated or distributed in the US)
- Referencing: Purchased print materials for content team, Purchased copyright clearance for all references; Program Management: Day time (US) follow-up for projects; on a need basis after global PM hours, Provided detailed action item list to PMs at the end of day
- Creative Team Function: Performed small creative fixes using InDesign, Photoshop, Illustrator and other Adobe programs
- Referencing Standards: Trained in electronic and print submission guidelines of various pharmaceutical including Amgen, Sanofi-Aventis and Wyeth.
Public Relations Coordinator
BtB Marketing Communications
2006.04 - 2007.01
- Provided public relations support for a variety of advanced technology clients
- Wrote and distributed press releases to online and print publications
- Provided pre-event and onsite support for large trade shows and symposia
- Updated online and print distribution lists with relevant contacts
- Assisted in the development of public relations support plans that included press releases, white papers, editor tours, trade show support and online and print articles
- Located and recorded all press mentions of clients.
Education
Bachelor of Science - Professional And Technical Communication
Rochester Institute of Technology
Rochester, NY05.2005
Skills
- Over 15 years of experience in clinical research trials for both pharmaceuticals & medical devices
- Global experience as System Admin/ SME for CTMS and eTMF
- Support implementation and data integration for both systems with Clinical systems/platforms
- Systems Administrator Certification for Veeva Vault platform
- Develop training materials and conducted training for system users across multiple platforms and clinical systems
- Act as the contact point and liaison for clinical systems vendors
- Provide monthly/quarter milestones and metric reports
- Created/reviewed Study’s material such as site essential documents and monitoring templates
- Reviewed various vendor reports for study risk migration
- Study Risk Assessments knowledge within Veeva CTMS
- Experience in Clinical Systems Implementation and Data Transfer
- Experienced monitor across multiple therapeutic indications, Phase 1-IV
Edcctmsexperience
6, 7, 1, 1, 5
Certification
- Veeva Vault Platform System Administrator – Oct 2022
- Veeva Vault Platform Business Administrator – Oct 2022
- Veeva Vault Platform Fundamentals – Oct 2022
- Veeva Vault CDMS for CRA – Apr 2023
- GCP Certification (NIDA Clinical Trials Network)
- Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites, 2019-2020
Cvversiondate
04/22
Personal Information
Title: Sr. Clinical Research Associate
Therapeutic Areas Expertise
Cardiovascular: Cardioversion- Device, Chronic Heart Failure, Peripheral intervention- Device
Digestive System: Ulcerative Colitis, IBD
Dermatology: Atopic Dermatitis
Licenses and Certifications
- Veeva Vault Platform System Administrator – Oct 2022
- Veeva Vault Platform Business Administrator – Oct 2022
- Veeva Vault Platform Fundamentals – Oct 2022
- Veeva Vault CDMS for CRA – Apr 2023
- GCP Certification (NIDA Clinical Trials Network)
- Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites, 2019-2020
Clinical Systems Experience
Veeva Vault Clinical (eTMF/CTMS): 6 years
EDC (Veeva CDMS, Medidata, Datatrak): 7 years
ERT/eDiary: 1 year
IRT/IWRS: 2 years
Collaborative Tools (Sharepoint, Box, Dropbox, Kiteworks): 5 years
Timeline
Clinical Systems Administrator
Chinook Therapeutics
2022.06 - 2024.08
Senior Clinical Research Associate
Reistone Biopharma
2021.03 - 2022.06
Senior Clinical Research Associate 2
IQVIA, Inc.
2019.01 - 2021.03
Clinical Research Associate
SynCardia Systems LLC
2013.03 - 2019.01
Clinical Trials Coordinator
Clinical Perspectives LLC
2012.10 - 2016.12
Project Manager
Complete Medical Communications
2012.02 - 2012.09
Consultant, Coordinator
H&H Consulting
2008.07 - 2009.07
Consultant, Projects/Grants Coordinator
MedCases LLC
2007.05 - 2012.01
Project Materials Coordinator
Indegene Pharmaceutical Solutions, Inc
2007.01 - 2008.07
Public Relations Coordinator
BtB Marketing Communications
2006.04 - 2007.01
Bachelor of Science - Professional And Technical Communication
Rochester Institute of Technology
- Veeva Vault Platform System Administrator – Oct 2022
- Veeva Vault Platform Business Administrator – Oct 2022
- Veeva Vault Platform Fundamentals – Oct 2022
- Veeva Vault CDMS for CRA – Apr 2023
- GCP Certification (NIDA Clinical Trials Network)
- Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites, 2019-2020
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