Senior TMF Manager - Inspection-Ready & eTMF (Remote)
Aura Biosciences
- Remote job
Aura Biosciences is seeking a Senior Manager, Trial Master File (TMF) to provide strategic oversight of TMFs across the clinical trial portfolio. You will ensure complete, inspection-ready TMFs managed in-house or via CROs in compliance with ICH-GCP, regulatory standards, and company SOPs. You will serve as the SME for TMF processes, systems, and standards, partnering with Clinical Operations, Regulatory Affairs, QA, and external vendors. #J-18808-Ljbffr Aura Biosciences
$150k - $185k
...newly created position of Senior Manager, Trial Master File (TMF). The Senior Manager,... ...partners — are complete, inspection-ready, and maintained in compliance... ...with CRO and eTMF vendor partners; oversee... ...Working Conditions Remote/hybrid or onsite Occasional...Remote workSeniorTemporary workWork at office$155k - $170k
Arcus Biosciences is seeking a Senior Manager, Records Management to lead TMF operations, reporting, and analytics. You will collaborate with... ...emphasizes SOP development, vendor oversight, and inspection readiness, with remote or Bay Area/hybrid options and a salary range...Remote jobSenior- ...aligned with ICH GCP E6(R3). The role oversees documentation, training, vendor quality, and TMF health, enabling inspection readiness across GxP functions. This role can be remote, hybrid, or based in Philadelphia, PA headquarters, offering a pathway to elevate quality...Remote workSenior
- ...Description Sponsor Dedicated Global Senior Project Manager (CTL level role) remote. The CTL is a key member of the... ...for quality and completeness of TMF for assigned projects. ~... ...for study management components of inspection readiness for all aspects of the study conduct...Remote workSeniorFull timeContract work
- ...is looking for a seasoned IT/Clinical Project Manager to oversee the implementation of Veeva Vault (CTMS, eTMF, and QMS). This role requires managing project... ...and business stakeholders to ensure operational success and inspection readiness. #J-18808-Ljbffr Talent GroupsSenior
$28 - $40 per hour
...a Clinical Trial Manager to join our dynamic... ...collaborate with senior leadership to plan... ...regulatory and audit readiness across all managed... ..., and regulatory inspections. Implement... ...trial master files (eTMF). Prepare, synthesize... ...time, on‑site (non‑remote or hybrid position...Remote workSeniorHourly payFull timeWork at office- ...study start‑up through inspection readiness, and serving as sponsor... ...cross‑functional teams and senior leadership. Roles and... ...aligning on standards, and managing issue escalation. Oversee eTMF quality, manage protocol... ...This is a full‑time remote position in the East Coast...Remote workSeniorFull timeFlexible hours
- ...Scientific Operations, Project Management, and Alliance... ..., maintain governance-ready dashboards and decision... ...operational and inspection readiness for key translational... ...advisor to the ADC TM Senior Matrix Leader, the... ...office applications, remote meeting tools such as...Remote workSeniorFull timeWork at officeLocal areaRelocation
- ...Quality Supervises: Quality Managers, Site Quality Managers, QA/QC... ...project quality plans, inspection and test plans, deliverables,... ...turnover packages. • Serve as a senior quality escalation point for... ...solar arrays, or commissioning readiness preferred. • Internal or...Remote workSeniorContract workFor subcontractorWork at office
$165k - $180k
...Description Summary The Senior Manager, Clinical Quality Assurance is responsible... ...studies. Responsibilities also include inspection readiness planning, management of health... ...Hayward, CA location (preferred) or can be remote based. The anticipated salary range...Remote workSeniorWork at officeShift work- ...role has been designated as ‘Remote/Teleworker’, which means you... ...work from home. The Delivery Readiness & Enablement team exists to... ...partners closely with Portfolio Management, PMO, Customer Success,... ...lifecycle. We are seeking a Senior Delivery Readiness & Enablement...Remote workSeniorFull timeWork from home
$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study... ..., compliance trend analysis, and inspection readiness. The role partners closely with clinical... ...and is not eligible for a fully remote work arrangement.Key Duties and Responsibilities...Remote workSeniorFull timeSummer workFlexible hours2 days per week- ...Job Description Job Description Senior Manager, Information Systems Join our... ...Support system validation, audit readiness, and regulatory inspections. Maintain change control processes... ...Environment: Hybrid (in-office and remote). Physical Requirements: Ability...Remote workSeniorWork at office
- ...Looking to take your project management expertise to the next level? Join us as a Senior Project Manager (Sr. PM) and lead... ...allocation. Maintaining inspection-ready documentation by leading key meetings... ...reason) Opportunity for remote/hybrid* working depending on...Remote workSeniorLocal areaWorldwideFlexible hours
- Palvella Therapeutics is seeking a Senior Director, R&D Quality to own quality oversight across the full research and development lifecycle—from GCP to GLP—driving inspection readiness and the build-out of scalable quality systems. This leadership role reports to the VP...Senior
- ...Team Opportunity Are you ready to move your career forward,... ...responsible for providing the field management personnel, from the craft... ...authorities for permits, inspections, and final approval of the project... ...Flexible work hours and remote work options Employee assistance...Remote workSeniorDaily paidContract workApprenticeshipFor subcontractorLocal areaFlexible hours
$95k - $130k
...Location: Remote with up to 100% travel Employment Status... ...The Site Manager is the on-site leader responsible... ...installation workmanship, ensure inspections are completed, and coordinate... ...Project Manager on execution readiness, schedule adherence, risk/issue...Remote workSeniorFull timeFor contractorsFor subcontractorImmediate start$167.19k - $226.19k
...You will be accountable for managing all FSP resources (CRA, CTA,... ...FSP trends and challenges to senior management Oversee... ...and quality targets Supports inspection readiness Supports local country site... ...Flexible work models, including remote work arrangements, where possible...Remote workSeniorWork experience placementLocal areaFlexible hours- ...receive an alert: Job Title: Senior Manager, Health, Safety, and... ...activities, including audits, inspections, and critical-control verification... ...and crisis-management readiness for U.S. operations, support... ...may include overnight stays, remote field locations, and occasional...Remote workSeniorFor contractorsLocal areaNight shiftWeekend workAfternoon shift
$120k - $200k
...Project Manager / Project Executive, Multi-Craft Industrial... ...(calibrated to seniority: PM, Senior PM, or Project... ..., fabrication, and inspection. The organization is... ...grade platforms. Field-ready safety acumen. Clear... ...-on owner mentality. Remote-manager profiles will...Remote workSeniorFor contractorsFor subcontractorWork at officeImmediate start$116.9k - $155k
...We are currently seeking a Senior Construction Project Manager specializing in life science projects... ...decision-making, root cause analysis, inspections and audit readiness, communications, management of... ...Face-to-face and/or remote daily interpersonal interaction...Remote workSeniorDaily paidContract workFor contractorsLocal area- ...This position is eligible for remote. Candidate must be located... ...Day in the Life" As a Senior Project Manager, you will be responsible... ...schedule impacts, permitting, inspections, jurisdictional constraints... ...profile. Oversee site readiness including permitting, AHJ coordination...Remote workSeniorPermanent employmentContract workFor subcontractorFree visaShift workWeekend work
$140k - $180k
Job Title: Senior Data Center Project ManagerCompany... ...Unit/Department: Management Location: Hybrid, regionally... ..., Soft Crafts, Inspection, Underground Maintenance... ...standards.The position is remote with approximately 50%... .... If you’re ready to be part of a company...Remote workSeniorFor subcontractorLocal area$161k - $175k
...Location: Remote Salary: $161-$175k Why Work With Us? At Candel, our people drive... ...Candel Therapeutics is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations... ...ensure high-quality, compliant, and inspection-ready biospecimen operations throughout the...Remote workSeniorFull timeContract work$145.6k - $276.8k
...develops, and deploys production ready and laboratory test solutions... ...for a full-time position of Senior Principal Test Systems... ...reviewsExperience with Earned Value Management System (EVMS) What We... ...designated as on-site, hybrid or remote.The salary range for this role...Remote workSeniorFull timeTemporary workWork experience placementInterim roleWork at officeRelocationFlexible hours$245k - $276k
...assembled an experienced team ready to take action because... .... The Opportunity The Senior Director, External... ...product launches, manage increasing manufacturing... ..., supply planning, and inspection preparedness Partner cross... ..., we proudly support remote work opportunities within...Remote workSeniorLocal area- ...growth, they are seeking a Senior Project Manger to drive... ...offers the autonomy of remote work, meaningful... ...projects with precision—manage punch lists, hand-over... ...Having Jurisdiction (AHJ) inspections. Empowering leadership... ...off and paid holidays. Ready to lead projects that...Remote workSeniorContract workFor contractorsLocal area
$145k - $170k
...for the company's global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs by overseeing inspection readiness, regulatory inspection management, internal quality audits, and partner audit activities. Lead the Inspection Readiness and Management Program...SeniorWork at office$150.1k - $227k
...values at the heart of it all.Ready to level-up your career at... ...Salesforce.The Customer Success Manager, Senior Manager is a highly... ...Indianapolis, Dallas, NYC, Boston. (Remote: Southern CA, South Florida)... ...forecasting, pipeline inspection tools Service Cloud: customer...Remote workSeniorFull timeWork at officeFlexible hours3 days per week- Senior Program Manager, Partner Services Success Americas Remote - New York, USA About Zscaler Zscaler accelerates digital transformation... ..., and strengthening partner readiness. You will serve as the critical... ...services easier to activate, inspect, and scale. Working across...Remote workSeniorWork at officeLocal area
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