Manager, Site Readiness - FSO

Fortrea's Full Service Team is hiring a Assoc Mgr/Manager, Site Readiness! This role is remote based in the US.

Job Overview:

The Manager, Start-up Operations is accountable for delivering on-time, high quality study start-up and maintenance activities within a country, or country cluster, as well as for central/local IEC/IRB submission, document collection, update of relevant systems and filing. This role will lead a startup team within a country or a cluster of countries that will work to activate study sites and ensure the filing of documentation into the eTMF system and completion of CTMS from the start to the end of the start-up period, including maintenance throughout the cycle of the study. The Manager, Startup Operations will also have direct line management responsibility for the start-up operations team in their country or a cluster of countries and oversight of all country-level client deliverables and timelines of start-up at the country and site levels. The Manager, Start-up Operations will act as a local point of contact for activities around start-up deliverables in the country. The Manager, Start-up Operations will have operational detailed oversight, ensuring right commitments and right timelines are met. The Manager, Start-up Operations will be the first line of escalation for performance issues and quality concerns and will have the necessary overview to confirm country start-up stays on track. This role will serve as the local Subject Matter Experts (SME) for start-up processes including timelines, training, and development of the start-up team at the local level and on local regulations. Has accountability for quality, performance and GCP compliance for start-up operations staff. Has accountability for delivery of all country level start-up deliverables and timelines. Has accountability for legal and regulatory requirement compliance for study activation and may include maintenance. Has line management responsibility for all start-up staff in country or in cluster of countries. Has recruitment, allocations, coaching, trainings, and talent development responsibility for Start-up operational (SU Ops) staff. Is responsible for resource and utilization management of start-up operations staff. May act as local contact for business development/client relations, works closely with strategic clients and ensures client satisfaction. Can be involved in local vendor management (sub-CRO and suppliers). May have additional line management assignment.

Summary of Responsibilities:

• Accountable to deliver start-up, maintenance and document filing in country on time and within study budget.

• Ensure quality and completeness of relevant systems for country and cluster.

• Look for opportunities to continuously improve country study start-up processes, cycle time and accuracy of projections (say/do ratio of 80% and above).

• Implement local lessons learnt to accelerate timelines.

• Resource allocation and line management of start-up operations staff in country or country clusters.

• Ensure cross-departmental collaboration and communication to ensure client satisfaction.

• Training and coaching of local resources on SOPs and company procedures.

• Ensure training record compliance with training matrix and training records are up-to- date.

• Act as primary point of contact (POC) for escalations.

• Have GCP oversight of direct reports by ensuring GCPs are understood and implemented.

• Contribute to "at risk" sites identification within the QC risk assessment.

• Provide input to relevant SOPs and standard plans/templates for use by start-up staff.

• Assist with coordination and implementation of on-boarding new direct reports ensuring GCP and local regulations training before work begins.

• Hold staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans.

• Hold staff accountable for compliance with project plan and adherence to contract obligations in quality, forecast for start-up and on time deliverables.

• Coach staff to own effective investigator relations and investigator oversight.

• When appropriate, acts as contact for local regulatory authorities on start-up issues in collaboration with the Country Head and Global Regulatory Submissions.

• Productivity/Financial Management for the Start-up team – In support of the Country Head:

• Communicate status of assigned workload for metric reporting.

• Perform weekly review of direct report billable hours and associated utilization against the budget, esca