The Senior Area Study Start Up is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area.

Responsibilities for Senior Area Study Startup Lead:

• Line manager for Area SSU Leads and responsible for their growth and development. Accountable for managing resourcing, hiring, performance reviews and talent development for designated area SSU staff.
• Provide start up focused strategic input on the area and country strategy, start up timelines, site profiles and risks assessment for the Area. Establish country/site activation plans including risk assessments and mitigation planning for the Area.
• Drive maintenance of country and site intelligence for assigned area.
  Provide area start up updates and metrics to Area Director, Area SSU Head, Global SSU Leads.
  Lead area quality management through risk-based thinking.
• Drive a learning environment (best practice sharing, and lessons learned) and ensuring continuous improvement in area/country performance by using innovative approaches, active analysis of Key Risk and Performance Indicators, metrics, milestones, and benchmarking.
  Manage identified risks to start-up through development of effective mitigation plans.
• Ensure audit/inspection readiness at all times and compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines. Work collaboratively with the Area SSU Head and Area SSU COMs to:
  Implement resourcing and training strategies in response to changes affecting Area, including effective organizational change management.
• Deliver consistent best practice approach to onboarding (incl. for Start-up Specialists) and defining best practice training curriculum for the SSU roles.
  Lead simplicity in process and approach, and enhancing agility, including leading area training and development of SOPs, job aids and work instructions in collaboration with other Area SSU COMs.
• Consolidate “lessons learned” across areas and incorporating into SSU training materials.
  Work collaboratively and partnering with all key stakeholders to facilitate cross-functional communication and collaboration.
  Participate in process improvement initiatives as required.

Responsibilities for Area Study Startup Lead:

• Overseeing and proactively driving activities of Country SSU Specialists for assigned trials.
  Proactively identifying and communicating issues impacting delivery and providing proposed solutions.
  Working with Area and Country leadership to identify training needs of the country start-up specialists and standardizing and facilitating training solutions for Start-up specialists within area.
• Accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned clinical studies within area.
  Working collaboratively with key stakeholders and establishing country/site activation plans including risk assessments and mitigation planning for the countries and sites within their area.
• Building country level ICF samples, reviewing IRB/EC comments on ICFs and routing for approval by required functional areas (as required by region).
  Driving start up activities including timely site selection and activation, EC submissions, document collection, and query responses.
• Providing area start up updates and metrics to Area Director, and Global SSU Leads.
  Running area start up meetings and driving priority action items between meetings.
  Collaborating with Global Site Contracting & Purchasing and Supplier Management, CTS and Regulatory Affairs, Global SSU Leads, Global CSM Leads, Country COMs and Country SSU Specialists to assure alignment between contract execution, CA and EC submission activities, site training visits and site activation planning.
• Leading quality management through risk-based thinking for the assigned studies.
  Driving standardization in area start up process and training, including sharing of best practices and lessons learned.
  Maintaining SSU performance metrics and KPIs for assigned studies.
• Ensuring audit/inspection readiness.
  Ensuring maintenance of intelligence database and Vault EDLs for countries and sites within their area.
• Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
  Participating in process improvement initiatives as required.

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