Senior Clinical Trial Associate
2 weeks ago
The Role
Genmab is seeking a highly skilled Clinical Trial Associate to join our team. This role is responsible for overseeing the filing of documents to ensure inspection readiness at the trial level and supporting the Clinical Trial Management team with key administrative activities.
Key Responsibilities:
eTMF Management:
- Setup and Maintenance: Establish and maintain the Sponsor eTMF, including trial, country, and site setup, and ensure timely closure.
- Oversight and Review: Conduct regular reviews of the eTMF, including TMF-Browser, Monthly Review, eTMF Spot Check, and classification as needed.
- Audit and Inspection Readiness: Prepare for audits and inspections by maintaining accurate and up-to-date documentation.
Meeting and Communication Management:
- Meeting Coordination: Coordinate logistics for Clinical Trial Team meetings, including emails, invites, recording, and filing in eTMF.
- Meeting Minutes: Prepare and distribute meeting minutes to the Clinical Trial Team.
- ODB Review Meeting: Coordinate logistics for Oversight Dashboard Review meetings, including report generation, invites, emails, and filing in eTMF.
- Clinical Trial Governance: Provide site and status updates to Clinical Trial Governance.
Plans and Resource Management:
- CTT Staff List: Maintain the Clinical Trial Team staff list in GenTrack/GenSense.
- Vendor List: Maintain the vendor list in GenTrack/GenSense.
- CTT Charter: Establish and maintain the Clinical Trial Team Charter.
- Trial Oversight Plan: Provide input to the Trial Oversight Plan.
- TMF Plan: Provide input to the TMF Plan.
Clinical Study Report Management:
- CSR Filing: Support the filing of appendices for the Clinical Study Report.
- Sponsor File: Establish and maintain the sponsor file, review, and QC trial-related documents in the eTMF system.
- Inspection Preparation: Support inspection preparations by maintaining accurate and up-to-date documentation.
- Site Contracts: Handle site contracts, ongoing updates of the trial dashboard, trial budget maintenance, and development.
- Meetings and Agendas: Arrange internal and external meetings, prepare agendas, and write minutes.
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