A small virtual oncology sponsor is gearing up to run a Transformational Phase IIb/III Trial in 2023. Indication- glioblastoma (GBM). Protocol amendment was submitted in Aug 2022, questions and discussions with FDA required. As of Dec 2022 the sponsor is focusing on closing a funding round, after which operations will ramp up. In addition to […]
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Small, MA based Phase 3 sponsor in need of a Data Management Lead. Will report to Head of Biometrics, experienced in all aspects of Data Management. This role is heavy on vendor management and data management oversight of CROs and external data managers, as well as data management database systems and technologies.
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1200 word content write up of 2023 Decentralized Clinical Trials predictions. Primary input- interview of thought leader, plus individual DCT trends research. To be published in pharmaceutical trade journal.
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Need for Strategic regulatory guidance and tactical support to further the progress of asset regulatory approval, including guiding direction of FDA communication and responses, submission strategy, health authority Q&A, Advisory Committee and other FDA meetings. Small, Northeast US small drug sponsor, main asset indication: treatment resistant UTI. Timelines: Phase 3 is currently enrolling, expected study […]
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Project Manager – Japan-based for a global labeling optimization project and a labeling text & artwork verification tool project Plan and manage the 2 projects noted above Help update the business cases to get them approved Experience managing vendor selections and implementations a plus Agile and regulatory labeling experience preferred. Business Analyst – Japan-based for […]
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Help required- someone who is very knowledgeable of Veeva APIs. This is probably not a large project, maybe just a couple of hours, but could lead to more. Here is the description of the business problem: we’ve been creating some forms for quick creation of Veeva objects, and that’s working fine… but I’m looking for […]
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Looking for an expert in validation of invitro methods that can assist in a technology validation roadmap for organoid high throughput screening.
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Verify study, country, and site level TMF completeness and generate missing documents lists and queries as necessary. Perform TMF reviews on site, country, or study level Ensure accurate completion and maintenance of TMF and tracking tools with project specific information QC Drug Accountability Work in Veeva eTMF Vault 20-30 hours a week for 6 months, […]
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Mid sized Northeast US based drug sponsor‘s goal is to update our StartingPoint authoring templates (SP) and incorporate relevant aspects of TransCelerate’s (TCB) Common. Tasks include conducting a Comparison of our current SP templates with TCB’s CPT, identify differences between TCB CPT from current templates; collect feedback from current users within the core team., execute updates to […]
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40 PDF study reports to be prepared for submission starting Oct 12, finishing Nov 9. Mostly tox approx 20 pages long plus attachments, some clinical. Longest study is approx 70 pages long. TOC to be bookmarked per guidance, hyperlinking throughout report body as necessary and to appendices and attachments. Must be proficient with ISI/TRS Toolbox.
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Trial projections indicate that too much supply is being utilized in the current dose administration methods used. Need an expert to advice on supply best practices such that product is being utilized more efficiently. Thinking a clinical affairs/trial design/clinical supply expert or perhaps even a clinician or nurse specialist could solve this issue for us. […]
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Expedite, manage and coordinate a multitude of interrelated activities for a submission team in the development of published submissions within the required timelines. Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely dispatch (by agency gateway; CD/DVD/paper; SharePoint upload) and archival of regulatory submissions, and effective maintenance of supporting documentation (e.g. […]
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This role will provide leadership in all aspects of clinical trial research and product development as well as regulatory interactions. Participation in the selection and oversight of the CRO to perform data management, programming, and biostatistics will be included in this role. Consultant will be available to participate in all meetings as needed, whether they […]
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CNS small molecule sponsor just launched phase 3, looking at commercialization strategy, product launch, etc. Senior Program Management role is soon to be empty. Current thinking is that it may take a while to find the right permanent replacement, looking at experienced executive consultant for the gap period. Must have small molecule NDA experience. Company […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities Primary responsibility includes oversight of clinical study execution, including project planning, resource management, CRA and CRO management, and ensuring all operational aspects of clinical trials […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities Primary responsibility of this position includes, but is not limited to the following: • Managing the Statistics, Statistical Programming and Data Management functions • Supervising […]
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Needed asap: seasoned programmer that has extensive experience with BIMO FDA guidance, programing ,and the creation of define.pdf etc.
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The Regulatory Operations Leader requires seasoned help for overflow activities, specifically for regulatory strategy related items, not operations. Marketing application filed in November, currently preparing for inspections, intensive labeling and Adprom activities. Further tasks to be discussed. Could be 10- 20 hours a week however to be discussed.
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Northeast US based drug sponsor in need of Regulatory Affairs consultant. There is a Head of Regulatory at present but is overloaded, needs an experienced second pair of hands to jump in and start adding value in the some of the following areas- Reg strategy, labeling, FDA required updates, interacting with partners, etc. to support […]
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We need a qualitative research who can help with analysis and reporting, Skills: qual research – self-sufficient; problem solve themselves vs. follow orders, and for qual researcher: synthesis, story telling and above all strong practical level of intelligence experience level: 5+ yrs. competency is more important estimated hours per week: if qual researcher who can […]
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