Edo Coordinator

**Job Title: External Development Operations (EDO) Due Diligence Coordinator**:
**Job Profile**:
**The EDO DD coordinator will enable the efficient and effective assessment and onboarding of external service providers(ESP) through consolidation of critical activities to enable clinical trial execution.**:
**The responsibility for data quality and integrity, as well as the protection of patient safety rights resides with the sponsor. Therefore, the sponsor must ensure oversight of any ESP working on Novartis’ behalf. Performing due diligence of ESPs is a crucial step in meeting this responsibility.**:
**The EDODD Coordinator will coordinate the due diligence of potential ESP’s Quality Management System, business and technical capabilities to qualify an ESP to perform services on behalf of Novartis.**:
**In addition, this role will ensure appropriate documentation from ESPs to support regulatory requirements**:
**Major Activities**:

- ** Coordination of supplier due diligence assessments of ESP**:

- ** Coordination Qualification / requalification of ESP**:

- ** Accurate and timely entry of supplier details into Supplier Information Management portal to trigger appropriate assessments**:

- ** Coordination of supplier performance metrics**:

- ** Trial Master File document management and upload for relevant documents from ESP**:

- ** Non-External service provider contracting/Purchase order management**:
**Key Performance Indicators**:

- ** Contributes to qualification/requalification cycle time improvement while maintaining high levels of quality to support clinical trial execution**:

- ** Strong analytical capability to structure data in most effective way**:

- ** Effective documentation of ESP relevant documents.**:
**Job Dimensions**:
**Impact on the organization**:
**Major**: Supporting the External Relationship Management Teams to qualify/requalify ESP. Work closely with ESP to ensure rapid and complete responses for data collection and evaluation. Leads and drives daily interactions and delivery of external services for multiple clinical trials.**:
**Ensuring external quality reputation of Novartis and minimizing compliance and regulatory risks of out
- sourced services.**:
**High**: Contributes to key EDO goals to standardize and simplify internal processes**:
**Ideal Background**:
**Education**:
**(minimum/desirable)**:
**Bachelor’s degree required**:
**Languages**:
**English: fluent written and spoken**:
**Experience/Professional requirement**:

- **1-4 years successful career track record in pharmaceutical clinical drug development and/or clinical supplier technology (BioPharma or with a CRO/Central Lab/Specialty Provider) including expertise in clinical operations and, management of outsourced trial activities**:

- ** Good understanding of clinical research and development including, quality & regulatory standards and policies relevant to defined services.**:

- ** Demonstrated ability of completing projects on time**:

- ** Excellent data analysis skills**:

- ** Excellent problem-solving techniques/skills**:

- ** Excellent project management experience**:

- ** Excellent communication and presentation skills**:

- ** Ability to work in a global team and matrix structure organization, meet timelines and work with mínimal supervision**:

- ** Good knowledge of GCP, GMP and FDA part 11**:

- ** Excellent understanding of clinical trial methodology, GCP and medical terminology.**: