Job Title: Senior Regional Site Manager
- Lead and coordinate Regional Site Mangers (RSMs) for assigned studies by providing monitoring expertise and ensuring deliverables (protocol, monitoring plan, SOPs, regulations) are met on time. Function as a liaison and primary contact between RSMs and Clinical Development, Global Clinical Trial Management, Data Management, Global Patient Safety & Epidemiology, Global Clinical Supplies Management, GSMO Program Lead, Regional Operations Manager (ROM), clinical sites, and vendors.
- In addition, the Principal Regional Site Manager holds other assignments, such as Lead Site Manager (LSM), Global Site Management Operations Subject Matter Expert (SME), CRO Monitoring Oversight Lead (CML) or any other project assigned by Global Site Management Operations management.
- Manage monitoring activities to ensure deliverables are met by maintaining project metrics and status of deliverables. Proactively communicate issues, risks and staffing needs to Program Lead, RSMs and Clinical Trial Team. Assist Program Lead with RSM selection for outsourced trials.
- Act as a resource for RSMs to answer questions, provide guidance, and participate in co-monitor visits. Make sure RSMs are maintaining standards established by GSMO.
- Monitor quality of data in EDC along with RSMs, Data Management, GSMO Program Lead and Clinical Trial Team (CTT).
- Review completed Site Feasibility Questionnaires, Site Qualification Visit reports and maintains all tracking reports (SIV, IMV, RMV, COV) for GSMO Program Lead.
- Develop monitoring tools for project to ensure consistency such as Protocol Specific Monitoring Plan and amendments, report guidelines, checklists, tool kits, etc. Provide PSMP training and assist with GSMO orientation sessions as necessary.
- Conduct/assist with RSM teleconferences and deliver training and information as required. Attend team meetings and disseminate information as necessary.
- Collaborate with CTT and GSMO PL in review of study specific eCRFs, completion guidelines, etc.
- Act as Lead Site Manager, resource for RSMs and mentor for new Lead Site Managers.
- Contribute to process development, improvement and documents to drive consistency.
- Maintain monitoring portion of study portal for RSMs.
- Maintain knowledge of ICH/GCP, regulatory requirements, Company SOPs, therapeutic area (protocol, amendments).
- May be responsible for monitoring 1 to 2 sites on assigned trial.
- Allied Health Professions degree (PA, RN, RPh), relevant clinical experience, or four-year life science degree.
- Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization.
- More than 5 year of industry experience.
- Prefer candidates that have functioned as a lead monitor/ have equivalent experience.
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance