Pratia is a site management organization with sites across seven countries. We bring tech-savvy, adaptable solutions to enhance access to innovative treatments. As Pratia continues to grow and initiate operations in the US market, we're hiring a Senior Site Manager to help facilitate that growth and drive feasibility and commercial success for both our clients and partners. Since 2012, we've carried out more than 3,000 clinical trials globally.
Are you ready to think outside the box and drive results? As a Senior Site Manager, you will:
- Oversee site operations, ensure compliance with study protocol throughout clinical trial duration. Ensure Patients' safety is prioritized by site team members.
- Manage site investigator relationships, implement site start up and operation plans, and assign tasks and deadlines to clinical teams within the site.
- Deliver clinical trial projects in line with Pratia's enrollment forecast and Pratia's commitment to our clients. Identify Patients' enrollment issues, implement corrective actions with site teams and any support functions (as applicable) to keep Patient enrollment goals on track.
- Direct and monitor clinical site operations efforts, identify resourcing needs, conduct quality reviews, and escalate functional, quality and timeline issues appropriately.
- Be accountable for the site's financial performance.
- Facilitate meetings between project stakeholders, management and leadership, as well as complete and maintain professional documentation of projects and deliverables. Develop standard operating procedures as needed, and assist in the auditing and monitoring of the site.
- Be responsible for timely and proactive site feasibility completions and evaluations, detailing the availability of critical local resources necessary for successful trial activation and enrollment and protocol execution once the trial period begins.
Knowledge, skills and abilities:
- Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology industries.
- Demonstrated knowledge of relevant therapeutic area and research design.
- Demonstrated ability to lead multidisciplinary teams of professionals, including vendor management.
- Demonstrated experience in client services in the clinical research business.
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade.
- Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
Requirements:
- Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience.
- Minimum of five years of experience in delivering effective clinical research management, including at least 2 years of experience in an SMO or CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies,
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