Site Activation Specialist
hace 2 meses
**Are you a brave mind?**
It takes insight, curiosity, and intellectual courage to transform healthcare. It takes brave minds. By reimagining a world without the consequences of disease, brave minds bring powerful ideas to reality. Not intimidated by complexity, they see possibilities and explore the improbable.
Join us as a **Site Activation Specialist****
**Job Overview**
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. May also include maintenance activities.
**Essential Functions**
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
**What Will Help You Succeed**
- 2-3 years clinical research experience, including 1 year on regulatory & start-up experience. Equivalent combination of education, training and experience.
- Advanced English Level
- Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills with ability to challenge, if applicable.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
**Unleash your potential to drive healthcare forward**
**Resumes must be uploaded in English. Otherwise it will not be considered.
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