(Sr.) Manager, Study Start-Up

The (Senior) Manager, Study Start-Up will provide leadership, mentorship, training and career development for assigned staff in the Local study start-up team to assure the objectives of Allucent and the sponsor are met. The Senior Manager, Study Start-Up will provide guidance to ensure that staff fulfil responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies. 

The (Senior) Manager, Study Start-Up will actively contribute to the department and CTO related systems and process improvements and development of (new) services to contribute to building a high performance team and organization, Allucent reputation and growth. 

The (Senior) Manager, Study Start-Up is a member of the Study Start-Up & Site Intelligence Management team. 

The (Senior) Manager, Study Start-Up manages the day-to-day functional and organizational activities for the assigned team by: 

• Defining and managing (future) project resource needs to meet project milestones  

• Reviewing the budgeted and recorded hours to ensure they are within acceptable working limits for active studies. Where needed, implements mitigation / improvement plans 

• Overseeing and managing the team’s project allocation, utilization and workload 

• Assisting the team in managing time and tasks to adhere to study budget and timelines, while achieving quality, compliance and efficiency 

• Actively participates in and drives the recruitment process (requisition opening, interviews, evaluate candidates, hiring decision) 

• Keeps oversight to ensure compliance to the SOPs and ICH/GCP/regulatory guidelines and best practices as well compliance to the department and project metrics. Where needed, initiates course of action to achieve/ sustain compliance and efficiency 

• Contributes to Study Start-Up system and process improvement initiatives. 

• Is an active member of the Study Start-Up & Site Intelligence management team art-Up & Site Intelligence management team 

To achieve a high performance team, quality in the project specific service deliverables, and as a result, contributing to Allucent reputation and growth, the (Senior) Manager, Study Start-Up: 

• Conducts dedicated line management, including performance management and performance evaluation/appraisals for direct reports. 

• Identifies, plans and executes staff training meetings, as well as contributes to design of and delivery of training curriculum 

• Manages staff onboarding and probation period evaluation 

• Manages staff career development and promotion, including succession planning 

• Nurtures a stimulating working environment, safe environment, collaborative spirit and open culture as per Allucent values to enhance staff engagement and development. 
• Drives / Supports compliance to Study Start-Up & Site Intelligence department KPIs  
• Actively facilitates knowledge sharing and lessons learned to achieve continuous improvement, and drives process improvement initiatives 
• Contributes as Subject Matter Expert (SME) in the field of Study Start-Up to the company’s Regulatory Intelligence as well as evaluation/improvement of processes including underlying instructions and templates within the Quality Management System  
• Supports the Study Start-Up & Site Intelligence Management team in analyzing audits, inspections, quality incidents, project issues, metrics and trends observed to contribute to building a high performing team and learning organization 
• Builds a culture where staff cross reference regulations / QMS / protocol and study plans to secure compliance and quality while working efficiently 
• Supports and contributes to audits / inspections and department CAPAs 
• Assure good communication and relationships with (future) clients and other external stakeholders (eg sites, vendors). 
• Contributes and takes part in business development activities, client evaluations, visits, proposals and bid defenses 

Requirements

• Life science, healthcare and/or business degree 

• Minimum 7 years of experience in drug development and/or clinical research 

• Previous experience in a line management role preferred. or for a senior Manager role a minimum of 2 years of line management experience or in a leadership capacity 

• Excellent knowledge of ICH/GCP, FDA and country regulations  

• Strong customer service orientation 
• Demonstrated professionalism and presentation of a positive image of the company 
• Demonstrated understanding of applicable medical/therapeutic area knowledge and medical