Trial Master File Processing

Trial Master File Processing

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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TransCelerate Common Technical Protocol integration into Starting Point Templates

TransCelerate Common Technical Protocol integration into Starting Point Templates

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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Sr. Clinical Project Manager

Sr. Clinical Project Manager

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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Patient Data Compliance and Governance needed for De-Identified Data project

Patient Data Compliance and Governance needed for De-Identified Data project

Emerging patient data technology start up in need of an independent expert on patient data privacy.  Company intends to ingest de-identified data from partner healthcare providers in the US, Germany, UK, France, Spain and Italy on an ongoing basis.  End goal is to simulate, as close as possible to true patient data without violating privacy […]

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Manager, Technical Services

Manager, Technical Services

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  The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility […]

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Clinical Quality Expert

Clinical Quality Expert

Flexible clinical (GCP) quality consulting services for a period of approximately four to six months. Support activities include defined tasks such as those related to SOP development and implementation, and incidental/undefined tasks such as consultation on specific issues or events. Regardless of the specific services, all support and advice will be provided in accordance with […]

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Clinical Contracts Consulting

Clinical Contracts Consulting

Contracts specialist to handle the outsourcing of function contract needs including but not limited to: primary contracts touch point for all vendors, coordinating all contract comment and negotiation rounds, working closely with established legal counsel to resolve contract issues, drive contract execution timelines, contracts document management, RFP creation, vendor proposal gathering and internal communication, vendor […]

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Clinical Contracts Expert

Clinical Contracts Expert

Clinical Contracts Expertise needed for comprehensive outsourcing support including but not limited to: RFP review, CRO Q&A consolidation, proposal distribution and analysis, CRO bid defense meeting coordination and follow up, proposal scorecard development and score compilation, drive internal decision making timelines and vendor selection, and lead all contract and budget negotiations through execution. Milestones and […]

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Clinical Contracts help needed- Sponsor-Site

Company background: Indication- brain cancer, company has orphan drug  status, phase 2 protocol has been approved by FDA.  Currently funded by National Cancer Institute, company needs to hit certain milestones to obtain additional funding, specifically, study start up.   The plan is to have 87 patients across 10 sites in the US.  They have 16 sites […]

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