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With nearly a decade of experience in Trial Master File (TMF) management, I’ve played a pivotal role in maintaining high standards of documentation quality and compliance. My career includes 8 years at Phlexglobal, a specialized eTMF services vendor, and 2 years with Syneos Health, embedded in a global CRO's FSP team within Sponsor’s Clinical Operations.I’ve worked on over 25 studies, including Malaria, Flu, Zoster, and RSV, and led multiple 6-month Periodic TMF Reviews and Veeva EDL reviews. My expertise in Veeva Vault began during a significant TMF migration project, where I not only mastered the system but also developed detailed work instructions and training sessions to enhance team engagement.Passionate about making an impact, I’m driven by the goal of supporting teams in delivering life-saving treatments. My skills in CDISC TMF Reference Model, Veeva Vault, and Learning Management Systems enable me to provide effective guidance as a TMF Subject Matter Expert.I’m seeking opportunities to further leverage my TMF expertise within Clinical Operations teams, focusing on TMF quality reviews, inspection readiness, and continuous improvement. If you’re looking for someone to ensure your clinical documentation meets the highest standards, I’d love to connect.
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Tmf Manager - FspIqviaMansfield, Gb -
Manager, Clinical Site EducationSyneos Health Jul 2022 - Jul 2024Partnered with Clinical Operations Leads and SMEs to develop and deliver 6 study-specific training LMS ePortals for clinical site staff. • Installed new coding into training matrix to save time and expenses for 300+ hospital, medical and facilities staff.• Developed and maintained study-specific Clinical Site Education Plan (CSEP), Training Matrix, Specifications and User Acceptance Testing (UAT) documents to document all role or tasks study-training requirements for all site personnel, liaising with vendors such as LMS ePortal Programmers.• Developed CSE budgets e.g. totalling £350,000 in response to Requests for Proposals (RFP).• Provided user support to diagnose technical issues within the ePortal, training modules and training compliance reporting questions and issues.• Coordinated and tracked timely submission of ePortal estimates and work orders against clinical study budgets.• Functioned as TMF SME, overseeing QC and uploading 1500+ documents in Veeva Vault. -
Clinical Site Education SpecialistSyneos Health Jul 2021 - Jul 2022Administered data entry for 10+ client-facing ePortal for the CSE Group. Collaborated with cross-functional teams on the timely entry and import of user, site, and delegation of authority log, investigator meetings and site initiation visit data. Assists with the administration and maintenance of ePortal/LMS, project timelines, users’ profiles, roles, permissions, user assignments, assessments, certifications, and overall site compliance in the ePortal/LMS. • Provided user support to diagnose technical issues within the ePortal, training modules and training compliance reporting questions and issues.• Distributed reports on site training compliance.• Consulted with and advises the Manager, Clinical Site Education regarding the structure, process and formatting of entries in the LMS.• Provided User Acceptance Testing support on ePortal.• Reconciliation/QC of UAT documentation across 45+ studies for TMF upload.
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Project Manager I (Tmf Specialist, Outsourced To Sponsor)Syneos Health (Previously Inc Research/Inventiv Health) Sep 2019 - Jun 2021Directed TMF setup, configured completeness reports, and developed expected document lists and gap analysis.• Managed TMF compliance for 25+ studies (Malaria, Flu, Zoster, RSV), leading 6-month Periodic TMF and Veeva Expected Document Lists (EDL) reviews.• Worked with Clinical Ops Leads and other Functional Leads to ensure high-quality, timely TMF submissions, maintaining audit-readiness.• Created a step-by-step guide for the new Veeva Vault TMF system with a focus on EDL, improving user adoption through demos and 1:1 support.• Participated in Trusted Process meetings (e.g., Kick-Off, Quick Start, Quality Finish) as TMF SME. • Delivered TMF status updates and drove execution through internal and sponsor meetings.• Designed and presented TMF training via teleconference, video, and in-person sessions. • Produced and distributed Completeness Reports and inspection readiness metrics.• Supported audits and ensured audit-readiness of TMF.• Regularly trained the project team on TMF status and health.• Participated in TMF process improvements and best practice initiatives.• Advocated for TMF in Quality Finish Meetings, guiding final QC and overseeing TMF shipment/archival.
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Query CoordinatorPhlexglobal Dec 2013 - Sep 2019Amersham, England, United KingdomeTMF Superuser – Internal Operations & PhlexEview.• Coordinated and tracked queries between Phlexglobal and Clients/CROs, providing metrics to improve client processes.• Supported team leads by optimising workflows to meet clients’ 7-day SLAs.• Served as SME for 2 clients (2012-2017) and a backup for 1 (2015-2016), mentoring junior SMEs. -
Client SecondmentPhlexglobal - A Pharmalex Company Now Part Of Cencora May 2018 - Jul 2018Amersham, England, United Kingdom• For 1 client across multiple studies; performed study document QC, resolved eTMF queries and generated completeness reports with metrics.
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Client SecondmentPhlexglobal - A Pharmalex Company Now Part Of Cencora Oct 2013 - Dec 2013Maidenhead, England, United Kingdom• Conducted QC of 1 study’s CCF documents in the electronic document system, removing duplicates and re-indexing missing or misfiled documents. Ad hoc review of additional studies.
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Documents Executive IiPhlexglobal - A Pharmalex Company Now Part Of Cencora Oct 2013 - Dec 2013Amersham, England, United Kingdom
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Documents Executive IPhlexglobal - A Pharmalex Company Now Part Of Cencora Jun 2013 - Sep 2013Amersham, England, United Kingdom
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Document Associate IiPhlexglobal - A Pharmalex Company Now Part Of Cencora Apr 2012 - May 2013Amersham, England, United Kingdom
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Documents Associate IPhlexglobal - A Pharmalex Company Now Part Of Cencora Sep 2011 - Mar 2012Amersham, England, United Kingdom• Processed documents within SLA e.g. 7 days, meeting productivity and quality targets set by the Line Manager.• Across 18 clients, handled document preparation for scanning, metadata indexing, and quality control, query creations before release into the PhlexEview eTMF system.
Theo Bailey Skills
Theo Bailey Education Details
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Left To Take Up Employment -
Guildford College, GuildfordBusiness National Diploma Btec -
Bishop David Brown School, Woking
Frequently Asked Questions about Theo Bailey
What company does Theo Bailey work for?
Theo Bailey works for Iqvia
What is Theo Bailey's role at the current company?
Theo Bailey's current role is TMF Manager - FSP.
What is Theo Bailey's email address?
Theo Bailey's email address is th****@****lth.com
What is Theo Bailey's direct phone number?
Theo Bailey's direct phone number is +4475050*****
What schools did Theo Bailey attend?
Theo Bailey attended University Of The West Of England, Guildford College, Guildford, Bishop David Brown School, Woking.
What skills is Theo Bailey known for?
Theo Bailey has skills like Etmf, Work Ethic, Document Indexing, Document Qc, Ich Gcp, Pharmaceutical Industry, Cro, Sop, Good Clinical Practice.
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Theo Bailey
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