The Regional Study Manager has the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.
The Regional Study Manager will plan and pro-actively manage the study to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate - and quality standards.
- Ensure that projects are delivered on-time, within scope and within budget and in compliance with applicable quality standards
- Manages the strategic aspects of projects, identify, analyze and minimize/mitigates any risk, including the implications of difference technical and operational choices.
- Communicates effectively with clients to successfully manage the relationship, identify needs and evaluate alternative business solutions and strategies.
- Develop and maintain Project Plans and timelines for their project and track progress
- Ensure all study team members -are adequately trained on project specific systems and procedures
- Implements, and maintains sound business practices
- Measure and evaluate project performance
- Manage the project budget, profitability and ensure invoicing is performed on time and in accordance with the scope of work
- Working with the Finance & Accounting team to analyze profitability, revenue, margins and utilization across their projects.
- Manage the resource allocation, on the project, in collaboration with respective line managers
- Facilitate internal and external communication
- Report and escalate to management as needed
- Establish and maintain relationship with third parties/vendors
- Manages high-level deliverables across the organization
- Participate in capability presentations/bid defenses, as needed.
- Continually defines ways to increase customer satisfaction and deepen client relationships.
- Contribute in review/develop procedures, guidelines, SOPs, metrics as needed
- Contribute to the continuous improvement of clinical operations through participation in working teams/ initiatives as needed
- Provide performance feedback of the team members to the corresponding manager
- Bachelor’s Degree, preferably in life science or RN diploma
- 3 year of relevant experience as Clinical trial manager, study manager or project manager
- Strong experience in oncolgy studies
- Strong knowledge of clinical research regulations governing the conduct of the clinical trials and quality standards
- Understanding of project planning and metrics
- Ability to lead and manage staff
- Excellent oral and written communication skills in English
- Solid organizational skills and ability to prioritize
- Internal and external negotiation skills
- Ability and willingness to travel to 10%
- The opportunity to be part of a friendly, supportive team and work with exciting technologies
- Home based flexibility
- Competitive salary + benefits
- Opportunity to work on a complex trial in challenging therapeutic area