Sammanfattning
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 in a hybrid working approach.
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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