Zusammenfassung
The Central Integrated Scientific Review Committee Lead (C-ISRC Lead) plays a key role in the review and approval of clinical documents across therapeutic areas in Development. Key to the role is following documents from C-ISRC submission to finalization, including meeting preparation, meeting management and documentation via minutes for completeness, consistency and process adherence.
In collaboration with the C-ISRC Chair and Co-Chair (Clinical Development Head) you will act as project manager in the review cycle and associated activities for high-quality and efficient C-ISRC meeting. Key outcomes are high-quality concept sheets, protocols and clinical development plans. Key systems include Collaborative Authoring Tool (CAT), and various tracking systems. Periodic participation in process/guidance review, best practice identification, trainings, C-ISRC process overview presentations, testing of new collaboration tools and other team projects is encouraged.
This role can be based in London, UK or Dublin, Ireland.
About the Role
Your responsibilities will include;
- Manages C-ISRC Review process for approximately 100+ clinical documents each year
- Ensures appropriate C-ISRC documentation and meeting management
- Assists in the development of high-quality protocols and other clinical documents via addressing C-ISRC processes/workflow related questions, and training and guidance as appropriate
- Works with various systems and trackers to ensure smooth C-ISRC workflow (includes CAT, Please Review, Document Management System, etc.); may work on system improvement as appropriate
- Serves as back-up to fellow C-ISRC Leads and may attend C-ISRC meetings to take minutes or co-facilitate the sessions
- Manages timely key data entry to create reports from appropriate systems and facilitate tracking of key metrics for the C-ISRC Office
- May assist in audits and inspection readiness as needed/related to C-ISRC process/documentation
- Supports other C-ISRC and Clinical Development projects and activities as appropriate (e.g. updating guidance, contributing to trainings and best practice sharing, etc.)
Minimum requirements
- Minimum Bachelor’s degree in science; Advanced degree, or equivalent, in science or healthcare preferred.
- 5+ years’ experience in pharmaceutical industry
- Strong knowledge of clinical drug development process, including trial design, GCP, regulatory processes, and clinical project management
- Working knowledge of IT systems and trackers, including Document Management System
- Excellent interpersonal, communication, presentation and meeting management skills
- Advanced medical/scientific writing and communication skills
- Ability to influence wide variety of stakeholders in a matrix environment.
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