Description
You will direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
Key responsibilities include:
- Overseeing the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy
- Developing, implementing and maintaining the Management Plan according to the Scope of Work and Project Plan
- Ensuring collaboration across Regulatory & Site Activation, including communication with regions and countries
- Creating and reviewing technical and administrative documentation to support business development and enable study initiation and maintenance
- Providing specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials
- Determining regulatory strategy and expectations for submissions and authorizations
- Assessing and reviewing the regulatory landscape and contributing to the collection of accurate regulatory intelligence
- Executing operational strategy for maintenance of clinical study approvals and authorizations
- Working with Quality Management to ensure appropriate quality standards
- Mentoring and coaching colleagues as required
- Ensuring accurate completion and maintenance of internal systems, databases and tracking tools
- May take a lead role in developing long-standing relationships with preferred IQVIA customers
- Delivering presentations and training to clients, colleagues and professional bodies as required
IQVIA creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.