Clinical Documentation Associate II
- Active study team member for assigned studies.
- Ensures real-time inspection readiness of clinical documentation by collaborating with Artifact Owners, reviewing assigned TMFs to ensure accuracy and completeness, and tracking and reporting status to study team(s).
- Develops and updates study-specific TMF structure documentation.
- Provides support for audits/inspections
- Update CTMS in a contemporaneous manner.
- Collaborates with CDC Operations colleagues.
- Complies with GCP, AbbVie SOPs and functional area processes.
- For assigned countries, may lead and execute study start-up activities including but not limited to:-Prepare submissions to central Ethics Committees. -Review documents and assemble packet required for IP release.
- Bachelor degree or international equivalent is required
- With at least 2 years Pharma experience or professional equivalent.
- Demonstrates analytical and critical thinking skills.
- Operates with limited oversight
- Good oral and written communication skills.
- Working knowledge of clinical documentation business procedures .
Equal Opportunity Employer Minorities/Women/Veterans/Disabled