Clinical Project Manager, RWE, home based
Posted Aug 16, 2021
The Project Manager has the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.
The Project Manager will plan and pro-actively manage multidisciplinary study teams (including Site Management, Data Management, Statistics, Medical Writing, Regulatory and Safety) to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate - and quality standards. In larger studies the Project Manager could be responsible for managing parts of the project, e.g. Site Management.
- Ensure that projects are delivered on-time, within scope and within budget and in compliance
- Contribute in review/develop procedures, guidelines, SOPs, metrics as needed 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
- Manage the execution and conduct of the RWE projects.
- 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 to the continuous improvement of clinical operations through participation inworking 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 in clinical research
- Minimum of 5 year experience in observational, non-interventional research, including prospective and retrospective studies
- Experience in epidemiology, NIS/RWE design, analysis and implementation is a plus.
- 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%
- Private Health Coverage
- Corporate Pension Plan
- Life Insurance
- Global General Liability Insurance
- Global Travel Insurance
- Home-based Allowance
- Internet reimbursement
- Flexible working schedule