TMF Governance Lead for Audit-Ready Trials
CSL Plasma Inc.
CSL Plasma Inc. seeks a seasoned TMF professional to lead governance and oversight of Trial Master File infrastructure. You will drive process improvements, ensure regulatory compliance, and coordinate with cross‑functional teams and vendors to maintain inspection readiness. Responsibilities include overseeing TMF systems, supporting audits, and delivering KPI‑driven reporting. Strong communication and global regulatory experience are essential for success in this role. #J-18808-Ljbffr CSL Plasma Inc.
- ...matters Every clinical trial CSL runs depends on a... ...archive. Getting the TMF right keeps inspections... ...Responsibilities TMF Governance & Process Management -... ...expectations. Inspection & Audit Readiness - Support internal and... ...& Team Development - Lead, coach, mentor and...Suggested
- A leading recruitment agency in the United States is seeking an experienced candidate to assist with Inspection Readiness Preparation. The role involves leading diverse CRO teams through the Inspection... ...extensive knowledge of clinical trial documents. The ideal candidate will...Suggested
- CBRE seeks a Facilities Audit Readiness Program Lead to own audit readiness and 5S across multiple facility areas, including mechanical spaces and yards. This hands-on role coordinates inspections, corrective actions, work orders, and continuous improvement with site leadership...Suggested
- ...Vice President, Alpha Product - Interoperability Manager to lead governance and service delivery across Aladdin-related Back/Middle... ...BRS, Global Delivery, and investment operations to ensure audit readiness and data integrity. The role requires 5-8+ years in fund operations...SuggestedFlexible hours
$263k - $328k
...collaboration, we’re building a future-ready team that thrives in dynamic... ...Search & Evaluation Late TA Lead, Immunology? The job is in our... ...asset potential, understand trial designs & clinical endpoints,... ...access assessments to support governance decisions.Partner closely...SuggestedFull timeWork at officeWorldwide3 days per week- ...Advanced Behavioral Health is seeking a Documentation Manager to oversee center documentation, ensure regulatory compliance, and lead audits. You will support the Director and Program Specialists, driving quality systems and person-centered processes. You will mentor staff...
$108k - $135k
...its comprehensive technology, actionable insights, and industry leading support. Backed by over 25 years of experience and... ...of financial advice, visit The Team You’ll Join The Pricing Governance Lead will join a highly collaborative and growing team responsible...Remote work- Envestnet is seeking a Pricing Governance Lead to drive disciplined, scalable pricing across customer deals. You will own Deal Desk operations, pricing governance, and cross-functional collaboration with Sales, Finance, Legal, and Product. The role emphasizes developing...Remote job
- Dormont Manufacturing Co in Upper Providence is seeking a leader for the RTSM function that focuses on optimizing randomization and trial supply operations. The ideal candidate will work closely with various teams to ensure high-quality delivery for clinical studies while...
- ...Vendor Management to oversee end-to-end FSP resources for Clinical Operations. This role drives workforce planning, budgeting and governance in collaboration with global leaders and vendors. The hybrid role requires onsite presence at Waltham, MA with at least 3 days on...Relocation3 days per week
$137k - $235.75k
...Operations Job Sub Function Clinical Trial Project Management Job... ...functional deliverables. The TDL leads a cross-functional team trial... ...inspections and internal QA audits. Ensure that the trial team operates... ...constant state of inspection-readiness, collaborating with R&D...Contract workLocal areaImmediate startRemote work- ...remediationPartner with IAM to align credential lifecycle, rotation, and governance controlsLead cross-team coordination for detection response... ...work for the long-term financial wellbeing of our clients. To lead through product and services that transform our clients' lives....Full timeWork experience placement
- Senior Accountant in Wayne, PA is an onsite opportunity to lead month-end close, financial reporting, and GL across multiple entities... ...statements, and collaborate with external accountants on tax filings and audits. Ideal candidates have a Bachelor's in Accounting or Finance, 5+...
- ...a QC Senior Scientist - Microbiology in King of Prussia, PA, to lead microbiology testing of drug products and raw materials, ensuring... ...analysts, review data, and support regulatory submissions and audits, working across Quality, Manufacturing, and Technical Operations...Weekend work
$129k - $153k
...structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now... ...with GRAST members to achieve regulatory deliverables (including leading assigned tasks) while fostering individual accountability, ‘team...Full timeWorldwideRelocation package$253k - $309k
...member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.Madrigal’s medication, Rezdiffra (resmetirom... ...to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis...Full timeFreelanceWork at officeLocal areaFlexible hoursNight shift3 days per week- ...strategy for the integrated DG, CS, and BC Audit and Enhanced Gemba program, aligning... ...representing the function in cross-functional governance forums with Logistics, Trade Compliance,... ...of relevant experience. Experience leading an audit program, including developing risk...Local areaRemote work
$144k - $176k
...team is connected by our shared purpose: leading the fight against MASH.Madrigal’s medication... ...(F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment... ...in regulatory inspections or sponsor audits.• Familiarity with data review and visualization...Minimum wageFull timeWork at officeLocal areaFlexible hours$75k - $105k
...presentations preferred Experience building and leading high-performing, innovative, and... ...facilitating site integrations Lead governance frameworks for operational technology,... ...standards and cybersecurity protocols Handle readiness, commissioning, and support for...Full timeWorldwide$245k - $285k
...Aardvark Studios is seeking a COO to lead operations in Conshohocken, Pennsylvania. The successful candidate will have a proven track record in operational leadership and will be responsible for improving systems, developing teams, and driving measurable results. The...- ...possibilities quite this beautiful. GENERAL SUMMARY & SCOPE The Lead Cashier (LC) is responsible for the efficiency of guest... ...displays, supplies, and impulse fixtures to ensure guest-readiness at all times. Maintain prompt, regular attendance. People...Work experience placementLocal areaFlexible hoursShift workAfternoon shift
- INC Research is seeking a Biostatistician who will provide biostatistics consulting throughout all phases of drug development, ensuring compliance with regulatory requirements. The ideal candidate will have a Ph.D. in Biostatistics or an MS with considerable experience....
- GlaxoSmithKline in King of Prussia, Pennsylvania seeks a qualified professional to lead small molecule drug substance activities from lab development to commercial manufacturing readiness. You will work closely with various teams to deliver safe and reliable medicines....
- ...Manager II within the Global Life Sciences Finance leadership team to lead Life Sciences Planning & Analysis activities, deliver insights,... ...planning, monthly forecasting, close support, and executive-ready analysis to drive performance. The Manager II acts as a partner...
- State Street seeks a seasoned professional to partner across Global Cybersecurity, leading workforce planning, budgeting, procurement governance, and vendor management. You will transform processes, deliver dashboards, and provide executive-level insights for strategic...
- ...seeks a Manager, People Analytics & Insights to lead data-driven workforce insights at the intersection... ...You will transform complex data into clear, action-ready recommendations for senior leadership, addressing governance, analytics standards, and multi-country...
- ...Manager in King of Prussia, PA. This role involves driving merchandising and operational practices, ensuring a customer-ready store environment, and leading store adherence to company policies. The Merchandise Manager will oversee inventory management, visual merchandising...
$17 - $27.75 per hour
...Today, it is a global lifestyle brand that designs extraordinary things for the everyday, delivering seasonal collections of handbags, ready-to-wear, jewelry, footwear, home décor, and more. Known for its rich heritage and unique brand DNA, Kate Spade New York offers a...Work experience placementSeasonal workShift work- ...P&C and specialty risk division of AXA, seeks an Underwriting Governance & Controls Senior Analyst in the Americas region. You will support... ...with regional underwriting leaders, CUO, risk, and internal audit to strengthen controls across all products and functions, while...
- ...seeking a Senior Leader for Global Clinical Trial Operations (GCTO) Program and Study... ..., high-quality study execution. You will lead cross-functional teams across clinical operations... ..., risk management, and regulatory readiness in a complex global portfolio. #J-18808-...
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