Study & Site Operations Country Manager - Saudi

2 months ago


الرياض, Saudi Arabia Novartis Full time

**Summary**:
Job Purpose:
The SSO Country Manager is accountable for all country clinical operation activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials. The SSO Country Manager is responsible for implementing the Study & Site archetype and Hub/Cluster/Country strategy, while delivering to Country budget and productivity targets in line with Study & Site and local business objectives. Operationally responsible for building a high performing team culture and including performance management and established monitoring procedures in accordance with GCP, ICH and local regulations. The SSO Country Manager is responsible for monitoring integration within Country CSO and Medical Director to ensure alignment on portfolio strategy, prioritization, and performance to aligned objectives for GDD trial delivery.
The SSO Country Manager can also undertake additional responsibilities as GDD Country Coordinator (if applicable refer to separate GDD Country Coordinator Role Profile).

**About the Role**:
**Job Purpose**:
The SSO Country Manager is accountable for all country clinical operation activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials. The SSO Country Manager is responsible for implementing the Study & Site archetype and Hub/Cluster/Country strategy, while delivering to Country budget and productivity targets in line with Study & Site and local business objectives. Operationally responsible for building a high performing team culture and including performance management and established monitoring procedures in accordance with GCP, ICH and local regulations. The SSO Country Manager is responsible for monitoring integration within Country CSO and Medical Director to ensure alignment on portfolio strategy, prioritization, and performance to aligned objectives for GDD trial delivery.
The SSO Country Manager can also undertake additional responsibilities as GDD Country Coordinator (if applicable refer to separate GDD Country Coordinator Role Profile).

**Accountabilities**:
**Portfolio execution strategy**
- Implements the defined Study & Site Operations and OPC country structure monitoring strategies to deliver country business and trial strategy objectives in close collaboration with the SSO Cluster Head Portfolio, Clinical Research Associate (CRA) Manager and Country CSO and Medical Director
- Aligns Country monitoring objectives to the SSO Country Head (OPC) and country CSO/Medical Director
- Identifies and implements innovative practices and patient engagement strategies in collaboration with Clinical Research Associate (CRA) Manager, Country CSO and Medical Director within the country to advance clinical trial planning, execution, and quality

**Allocation, initiation and conduct of trials**
- Responsible for the alignment between SSO Feasibility Manager and relevant medical/clinical functions to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I-IV trials)
- Drives collaborative engagement model with Cluster Head Portfolio to ensure Country participation in GDD trials is aligned with the overall OPC Country structure portfolio execution strategy
- Ensures Country trial site selection, activation, enrolment, resource allocation, timelines and budget commitments are delivered per established trial objectives

Builds and maintains effective site relationship management to ensure site performance to
trial commitments and delivery of quality monitoring

**Delivery of quality data and compliance to quality standards**
- Actively monitors the KQI’s and develops, maintains and follows-up on the yearly process control

plan in the Country to ensure adherence to clinical data standards, prevailing legislation, GCP,
Ethical Committee and SOP requirements
- Is responsible for Country Monitoring issue identification, escalation and resolution pathways

in CPO, partnering with relevant medical/clinical functions, Country QA, GLF’s and Dev QA
- Actively manages Country issue identification and resolution in relation to CPO and trial audits,

inspections and delivers to CAPA implementation requirements
- Promotes a compliance culture advocating the adherence to highest standards and ethical
- Is accountable for Country adherence/compliance to SOPs and roll-out/adoption across the

Country Study & Site structure for required training curricula per GDD targets
- Responsible for local Study & Site SOPs creation and lifecycle management as well as

implementation of all relevant country rules and regulations
- Drives continuous improvement in Monitoring operations and fosters best practice sharing

within the Country
- Primary contact for FSP/BiS vendors to ensure overall quality & performance
- Responsible for escalation and follow


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