Remote TMF Specialist — QA & Regulatory Documentation
ZP Group
- Remote job
Piper Companies is seeking a TMF Specialist to join a clinical research organization in Bethesda, MD in a hybrid role with three remote days per week. The successful candidate will manage TMF set-up, quality management, reporting and QA, ensure compliance with FDA, ICH, EMA, and regulatory SOPs, and coordinate TMF documentation cross-functionally. Qualifications include 1+ year TMF experience and a BA/BS in science or healthcare; experience with Veeva Vault and Trial Interactive is preferred. #J-18808-Ljbffr ZP Group
$50k - $85k
...Companies is looking for a TMF Specialist to join a clinical research... ...is a hybrid position with 3 remote days out of Bethesda, MD. Essential... ...Accountable for overall TMF document quality and completion,... ...specifications, ICH/GCP guidelines, regulatory requirements, and applicable...Remote workRegulatory3 days per week- ...client to fill a CTA role focused on TMF management, site start-up, and essential document collection. The position supports... .... This contract is 12 months and remote, offering exposure to multiple... ...expertise in study conduct and regulatory readiness. #J-18808-Ljbffr Real...Remote jobRegulatoryContract work
- ...Senior Clinical Document Specialist This position is responsible for collecting... ...maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good... ...a 6 month full time contract, remote US. Responsibilities Work...Remote workRegulatoryFull timeContract workFor contractorsFlexible hours
- ...onsite 4 days per week and one day remote. You will support front office... ...booking, logistics, inventory and QA compliance. Ideal candidates have... ...familiarity with protein markets and regulatory standards. Strong coordination and documentation skills are essential. #J-18808-...Remote workRegulatory
- UASI is seeking a Clinical Documentation Integrity Specialist to join our fully remote CDI team in the United States. The role focuses on improving documentation accuracy, ensuring regulatory compliance, and supporting high-quality patient outcomes through physician queries...Remote jobRegulatory
$70k - $90k
...innovation-driven Quality Assurance Specialist (GxP) to support the... ...decentralized trials. The QA specialist will directly support... ...QA procedures. GCP Regulatory Document Review: Conduct comprehensive... ...Location : Remote within the United States. This...Remote workRegulatoryFull timeTemporary workWork at officeLocal areaWorldwideVisa sponsorshipWork visaFlexible hoursShift work$129k - $156k
...commitment to protecting and saving lives.JOB SUMMARY The QA Specialist I, Document Control is a senior individual contributor and the accountable... ...with US FDA 21 CFR Parts 210, 211, and applicable global regulatory expectations. The incumbent serves as the site subject...RegulatoryLocal area- ..., compliant case reports. This remote, contract-to-hire role supports... ...Department from Dallas, TX, handling QA questions and providing... ...The role emphasizes rigorous documentation, adherence to client specs, and adherence to regulatory standards, with compensation details...Remote workRegulatoryContract work
- ...and its talent-first flexible/remote work approach, see below and... ...The Compounding Operations Documentation Specialist is responsible for the... ...activities are aligned with regulatory requirements (FDA, EU, etc.)... ...liaising between Compounding and QA teams. Good Manufacturing Practices...Remote workRegulatoryFull timeWork at officeLocal areaFlexible hoursShift work
- Piper Companies in Bethesda, MD, is seeking a TMF Specialist for a hybrid role with three remote days per week. The position focuses on TMF setup, quality management, and inspection readiness, ensuring documentation conforms to ICH/GCP, FDA, EMA, and SOP standards. Ideal...Remote job3 days per week
$89.78k - $108.79k
Senior Specialist, Quality Assurance InvestigationsWorking... ...Senior Specialist, QA Investigations, is responsible... ...internal policies and regulatory guidelines.Proficient... ...centers. Employees in remote-by-design or lab-based... ...should consult that document to determine if they...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workFlexible hoursShift work$20.69 - $31.03 per hour
...Reporting to the Manager, QA & Speech Analytics, the QA Specialist is responsible for... ...it pertains to legal and regulatory compliance, professionalism... ...T-TH in office and M & F remote) is required. Responsibilities... ...with Ability to document quality findings with specific...Remote workRegulatoryHourly payFull timeTemporary workWork at officeLocal area- ...Support the review and management of study documents (e.g., Informed Consent Forms, Case... ...maintain study manuals and reference binders (regulatory, pharmacy, laboratory, etc.), ensuring... ...Perform scheduled Trial Master File (TMF) reconciliations in partnership with the...RegulatoryWork at officeWork from homeWorldwide
- ...Regulatory And Site Start Up Specialist Remote, South Korea Precision for Medicine is not your typical CRO. At... ...review and adaptation, Essential Document collection and quality review, supporting... ...times and file documents as per TMF plan and/or study specific plans...Remote workRegulatoryContract workLocal area
$75k - $90k
...life-saving therapies. The Specialist I, Quality Assurance is an integral... ...in the management and documentation of quality processes-including... ...aids in maintaining regulatory compliance and enhancing our... ...factors as permitted by law. For remote-based positions, this range...Remote workRegulatoryFull timeLocal area- ...Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with... ...compliance issues and findings. Oversee TMF maintenance done by CROs and ensure final... ...knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for...Regulatory
$65k - $97.5k
...Shift: 1st Workstyle: Remote Eligible up to 20% Career... ...Job Purpose The Purchasing Specialist (EX2) position within Recycling... ...customer (dealer) satisfaction, regulatory compliance, profitability,... ...Audit Support – IN dealer system document accuracy & department SOP...Remote workRegulatoryFull timeTemporary workWork experience placementWork at officeRelocation packageShift work$40 - $45 per hour
...Clinical Research Organization, is seeking a TMF Specialist to join their team. As a TMF... ...Operations support team, helping ensure trial documentation is organized, accurate, and inspection... ...specifications, ICH/GCP guidelines, regulatory requirements, and applicable SOPs....RegulatoryWeekly payTemporary workFlexible hours- ...Companies in Bethesda, MD is seeking a TMF Specialist to manage TMF setup, quality oversight... ...environment. You will coordinate documentation, audits, and reporting to ensure inspection... ...Vault or Trial Interactive), strong regulatory knowledge (ICH-GCP), and excellent organizational...Regulatory
- Piper Companies is seeking a TMF Specialist in Bethesda, MD to manage TMF setup, quality oversight, and documentation across clinical trials. The role focuses on maintaining... ...readiness, ensuring compliance with ICH-GCP and regulatory standards, and supporting client...Regulatory
$105.06k - $129.78k
...Biopharma is seeking a Senior Specialist, Quality Assurance to... ..., Supply Chain, Regulatory Affairs, and other... ...reviews and approves GMP documentation, supports investigations... ...provides on-the-floor QA oversight, and... ...work onsite, working remotely when appropriate. Salary...Remote workRegulatoryNight shift$96k - $125k
...compliance with applicable legal and regulatory requirements.... ...in directing BSU technical specialists for regional ITS training of... ...promptly follows up on same, documenting the file accordingly.Stays alert... ...work independently, from a remote location.Must be able to maximize...Remote jobRegulatoryFlexible hours- ...397Reference26-01208Remote50% Remote Job description: We are seeking a Senior CQV Specialist to lead commissioning, qualification... ..., risk assessments, and GxP documentation. Drive execution activities,... ...during internal and regulatory inspections as needed. Requirements...Remote workRegulatory
$210k - $225k
...NC. This is a hands-on QA leadership role sitting... ...Quality System (Document Control, Training, Deviations... ...Vendor Oversight Plans, TMF Plans, Protocol... ...readiness, mock inspections, regulatory inspections, and response... ...Durham, NC (Hybrid) — Remote considered, East Coast...Remote workRegulatoryFull timeContract workFor contractors- Piper Companies is seeking a TMF Specialist to support trial master file management in Bethesda... ...on TMF set-up, quality oversight, regulatory compliance, and ensuring inspection readiness... ...records. The candidate will maintain document quality, respond to client requests for...Regulatory
- Piper Companies seeks a TMF Specialist to join a clinical research organization in Bethesda, MD. The role focuses... ..., and maintaining inspection-ready TMF documents. You will ensure compliance with ICH-GCP and regulatory requirements, coordinate document filing, and support...RegulatoryFor subcontractor
- ...Working remotely as a full-time Health Information Specialist, the candidate will manage protected health information and ensure... ...health information in accordance with regulatory standards Conduct audits and ensure documentation accuracy to maintain compliance Collaborate...Remote workRegulatoryFull time
- ...activities, the full-time International Trade Regulatory Specialist will ensure adherence to regulations... .../import requirements while working remotely. Key responsibilities Ensure... ...Familiarity with global shipping processes and documentation Strong analytical skills to assess...Remote workRegulatoryFull time
- ...health information, the full-time remote Health Information Management Specialist will manage medical record... ...collaborating with various teams to ensure regulatory adherence. Key responsibilities... ...participate in audits to uphold documentation standards Required...Remote workRegulatoryFull time
- ...809Reference26-01309Remote50% Remote Job Description: LabWare LIMS Configuration Specialist to support the LabWare 8 upgrade... ...candidate will translate regulatory, quality, and operational requirements... ...activities by providing clear documentation and traceability for...Remote workRegulatory
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