Study & Site Operations- US Country Head (Remote)

Band

Level 7

 

Job Description Summary

The SSO Country Head is accountable for all country clinical operations 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 Head is responsible for implementing the Study & Site Operations archetype and Hub/Country strategy, while delivering to Country budget and productivity targets in line with Study & Site Operations and local business objectives. Operationally responsible for building a high performing team culture and ensuring standardization across Development Units - including talent development, performance management and established monitoring procedures in accordance to GCP, ICH and local regulations.

The SSO Country Head is responsible for Study & Site Operations structure integration within Country CSO and Medical to ensure alignment on portfolio strategy, prioritization and performance to aligned objectives for GDD trial delivery. The SSO Country Head can also undertake additional responsibilities as GDD Country Coordinator (if applicable refer to separate GDD Country Coordinator Role Profile).

#LI-Remote
Internal Title: SSO Country Head
Location: Remote

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel

 

Job Description

Key Responsibilities:

Trial Monitoring strategy

• Defines and drives Country Study & Site Operations strategy to achieve Hub/Country business and trial strategy objectives in close collaboration with Americas Hub Head and US Medical
• Aligns country SSO objectives to global and hub SSO objectives and US Medical
• Identifies and implements innovative practices and patient engagement strategies in collaboration with CRMA, US Medical within the Country, as well as, in support of Hub strategies – to best advance clinical trial planning, execution and quality

Allocation, initiation and conduct of trials

• In collaboration with the US SSO Country Head Portfolio, defines and implements Country (Hub, where applicable) feasibility strategy to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I-IV)
• Identifies opportunities to build competitive advantage for global development trials within the Country by identifying trial level synergies for medical standard of care, local business drivers and site relationship management
• Drives collaborative engagement model with the SSO Country Head Portfolio to ensure Country participation in global trials meets GDD needs while ensuring alignment with Country/Hub strategy
• Ensures Country site activation, enrolment, timelines, resource allocation and budget trial commitments are delivered per established Hub/Country key performance indicators

Delivery of quality data and compliance to quality standards

• Actively monitors the KQI’s and the development, maintenance and execution of the yearly process control plan in the Country to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
• In collaboration with US SSO Field Head responsible for country monitoring issue identification, escalation and resolution pathways, partnering with relevant medical/clinical functions, Country QA, GLF’s and Dev QA
• Actively manages Country issue identification and resolution in relation trial audits, inspections and delivers to CAPA implementation requirements
• Is accountable for Country adherence/compliance to SOPs and, roll-out/adoption across Country Study & Site Operations for required training curricula per GDD targets
• Drives continuous improvement in Study & Site Operations, fosters best practice sharing within the Country and supports Hub best practice sharing

Management of people and resources management

• Is responsible for hiring, development, retention and succession planning of talent including US Field Monitoring Head, Study Start Up Head and Portfolio Head(s). 
• Is responsible for the allocation of Study & Site Operations resources within the Country SSO in collaboration with Hub Head (as appropriate)
• Manages, develops and recognizes Country perfo