Site Enablement Solutions Lead (SESL) supports clinical study sites by providing two tailored services to sites:
- In collaboration with Patient Recruitment & Enablement (PRE) Team, SESL supports clinical trial sites to optimize follow-through on protocol-specific patient referrals from Direct-to-Patient (DTP) campaigns by enabling sites to use IQVIAs site-facing Referral Hub platform.
- SESL places trained and qualified clinical research staff on site dedicated to a specific study protocol. These clinical research professionals support study sites with tasks such as EDC data entry and query resolution, study file maintenance, patient recruitment, engagement, and education, patient visit management, clinical supply maintenance, etc.
Responsibilities
- Working under guidance of assigned functional lead and is fully responsible for the implementation of site-level SES services for assigned sites for the study, including:
- Introduce services to site, encouraging site adoption
- Train and educate on site-facing tech tools and site worker services
- Engage with internal technology teams to ensure timely activation of sites
- Oversee referral flow at sites and follow up appropriately to ensure optimal referral funnel performance
- Collaborate with internal legal team to prepare, negotiate, and execute service agreement contracts with site
- Hire and oversee activities of temporary site staff.
- Manage invoicing and effort forecasting process for the assigned sites.
- As the sole contact for site, SESL is responsible for the maintenance of site relationships to ensure continuous feedback loop.
- Work closely with functional lead to monitor impact of SES support.
- Collate site feedback to suggest additional operational and tactical recommendations for sites and Sponsor based on study performance.
- Based on scope, SESL may co-manage or independently manage these projects maintaining full responsibility for site relationships and operational oversight for assigned sites.
- Contribute to ad-hoc process development and process improvement projects.
- Other duties may be assigned.
- In-depth knowledge of clinical trial conduct at clinical study sites for pharmaceutical research.
- Experience engaging with sponsors, site staff, and CRO study team members throughout the lifecycle of a clinical trial.
- Knowledge of patient recruitment practices and clinical trial site-based processes.
- Knowledge and ability to apply ICH/GCP and applicable regulatory guidelines.
- Computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word, and Microsoft Excel.
- Excellent written and verbal communication, as well as presentation skills, including good command of English and Polish.
- Team management and/or project management experience.
- Effective time management and organizational skills and ability to manage competing priorities.
- Ability to adapt and be flexible in a global and dynamic work environment with changing priorities.
- Excellent interpersonal and problem-solving skills with ability to build and maintain strong relationships with colleagues, site stakeholders, and sponsors; ability to use consultative approach to solve challenges.
- Ability to influence effectively within functional team and project teams including Therapeutic Strategy Leads, Project Leads, Clinical Leads, CRAs, and sponsor.