Medical Communications Writer needed to attend and write the executive summary for an executive meeting of the American Society of Echocardiography taking place in Washington DC the morning of Tuesday, June 27. Someone local or within driving distance to both DC and NY- if successful, this engagement will most likely be repeated in March in […]
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Study Report QC- Approximately 80 pages of a study report, to be submitted in 510K. Final draft expected to be available April 15, looking for a QC completion date of May 1. Report will be provided electronically. Content QC required- checking study report body content against tables listings and figures. Formatting QC most likely not […]
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A software vendor specializing in pharmaceutical R&D statistical software seeks stats SME (subject matter expert) review and feedback of new release. Tasks include- getting a demo, temporary login, working with product manager, independently reviewing and testing features, and providing feedback including UI/UX (user interface/user experience), overall utility, competitive fitness, other. Deliverables: written report and presentation […]
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Small niche CRO requires RWD/RWE Stats Programmer Expert for ongoing project, anticipated time- 25%. Must have RWE/RWD stats programming experience- experience with datasets from EMR as well as EDC, ICD9 codes, etc.
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A niche CRO requires a strategic RWE expert for a long term project. Anticipated time is 25% FTE. Must be well rounded- have knowledge of regulatory submissions including RWD data, have been exposed to use of RWD as part of a trial such as a control arm, epidemiology methods for observational studies, and other aspects […]
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Small Phase 2 pharma pursuing oncology, stroke and potentially cerebral palsy indications. Need expert regulatory strategy part time but long term. 20 hours a month to start with variation expected. 2023 is a critical year for regulatory strategy- currently running a phase 2, sponsor had tried for a phase 2b transformation trial but FDA requested […]
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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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