Clinical Development Project Manager
3 days ago
CISRC Review Process Management
Manage the review process for approximately 100+ clinical documents annually, ensuring timely completion and adherence to company standards.
Key Responsibilities:
1. Coordinate C-ISRC documentation and meeting management processes, guaranteeing accuracy and compliance with regulations.
2. Collaborate with various stakeholders to develop high-quality protocols and other clinical documents via addressing workflow-related questions and providing training as needed.
3. Utilize multiple systems and trackers, including CAT, Document Management System, and tracking systems, to maintain smooth C-ISRC workflow and identify areas for improvement.
4. Serve as a backup to fellow C-ISRC Leads, participating in meetings, taking minutes, and co-facilitating sessions as required.
5. Manage data entry to generate reports from relevant systems, facilitating the tracking of key metrics for the C-ISRC Office.
6. Assist in audits and inspection readiness by reviewing processes and documentation related to C-ISRC activities.
7. Support other C-ISRC and Clinical Development projects, such as updating guidance, contributing to trainings, and sharing best practices as necessary.
Qualifications:
- Minimum Bachelor's degree in science; advanced degree or equivalent preferred.
- At least 5 years' experience in the pharmaceutical industry.
- Strong knowledge of clinical drug development processes, including trial design, GCP, regulatory processes, and project management.
- Familiarity with IT systems and trackers, including Document Management Systems.
- Excellent interpersonal, communication, presentation, and meeting management skills.
- Advanced medical/scientific writing and communication skills.
- Ability to influence various stakeholders within a matrix environment.
About Us
Nurturing innovation, collaboration, and expertise within our organization enables us to drive groundbreaking breakthroughs that positively impact patients' lives. By fostering an atmosphere of inclusivity, transparency, and respect, we strive to empower talented individuals like you to excel and achieve remarkable results.
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