Description
We are seeking a Site Activation Specialist to perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
The successful candidate will serve as a Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Key responsibilities include:
- Performing start-up and site activation activities according to applicable regulations, SOPs and work instructions
- Preparing site regulatory documents, reviewing for completeness and accuracy
- Ensuring accurate completion and maintenance of internal systems, databases and tracking tools with project-specific information
- Reviewing and providing feedback to management on site performance metrics
- Establishing and agreeing on project planning and project timelines
- Informing team members of completion of regulatory and contractual documents for individual sites
- Reviewing, tracking and following up the progress, approval and execution of documents
- Providing local expertise to SAMs and project teams during initial and on-going project timeline planning
- Performing quality control of documents provided by sites
- May have direct contact with sponsors on specific initiatives
The ideal candidate will have:
- A Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience
- 3 years clinical research experience, including 1 year experience in a leadership capacity
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills with ability to challenge
- Effective communication, organisational, and interpersonal skills
- Ability to work independently and prioritise tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
IQVIA creates intelligent connections to accelerate the development and commercialisation of innovative medical treatments to help improve patient outcomes and population health worldwide.