Description
We are seeking a Centralized Monitoring Lead (CML) to partner with the Clinical Lead and local country Site Monitors in project execution. The successful candidate will provide centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Key Responsibilities:
- Maintains Clinical Operations Plan and supports development of iSite Pack template, KDPMP and other tools/templates for DTE studies
- Ensures the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM and requests site monitor resources for site selection visits
- Verifies training compliance and system access for the site management team involved during the study start-up
- Tracks site activation related critical elements on an ongoing basis before Site Initiation and keeps CL and Start-up Lead updated about the status of the site activation
- Requests monitor resource for site initiation and site monitoring and verifies training compliance and system access for the site management team involved in the study site initiations
- Coordinates with all stakeholders to start the site initiation activities once all site activation critical elements are obtained/resolved
- Closely works with Site Monitor and CL during study execution phase with respect to recruitment and compliance to Clinical Operation Plan
- Performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion
- Supports CRA in management of Quality issues
- Manages DTE Alerts and other study specific triggers and reviews status of action items and follow-ups with relevant team members for closure of action items
- Escalates to Clinical Lead and PMA in case of significant delays in closure of action items if required
- Sample review of iSite Pack (DTE studies), closed and open action items, Site Level documents on TMF
- Reviews Site Visit reports (for smaller studies with less than 20 reports per month)
- Reviews the RM Dashboard and resolves any items that need attention
- Manages resourcing and transition of study team members during execution phase and provides training to Site Monitor, Central Monitor and Clinical Analyst Support if required
- Reviews and approves Investigator Payments and reviews and manages services requests received by CCO staff
- Provides study updates to Clinical Leads as per study requirements
Requirements:
- Bachelor's degree in life sciences or related field and minimum 2 years with relevant clinical research experience; or equivalent combination of education, training and experience
- Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements
- Familiarity with related systems and software’s utilized in clinical operations
- Strong leadership skills and strong written and verbal communication skills including good command of English language
- Results and detail-oriented approach to work delivery and output
- Good problem solving skills, planning, time management and prioritization skills
- Ability to handle conflicting priorities and attention to detail and accuracy in work
- Good software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences
Salary: zł151,200.00 - zł280,700.00 per year