Manager, Site Readiness - FSO

Fortrea•Durham, CA

3d•$110,000 - $125,000•Remote

About The Position

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.

Requirements

University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
In lieu of this required educational background the following relevant work history may be considered: Minimum of three (3) years supervisory experience in a health care or clinical research setting and Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
3 years supervisory experience.
7 years clinical research experience.
Relevant supervisory experience
Demonstrated ability to lead by example and to encourage team members to seek solutions.
Proven interpersonal skills.
Demonstrated ability to successfully participate as a member of a project team.
Demonstrated ability to successfully manage multiple competing priorities
Advanced planning and organizational skills.
Advanced oral, written and presentation skills.

Nice To Haves

Master’s or other advanced degree.

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.
Communicate status of assigned workload for metric reporting.
Perform weekly review of direct report billable hours and associated utilization against the budget, escalate outliers and assist the management team with mitigation.
Assess available resources, in context of project allocation, supply and demand, to resourcing team.
Engage in resource management activities for direct reports or across a project team.
Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports.
May act as Manager, Start-up Operations for other countries besides the one-off residence.
May serve as the Start-up Country Head.
May manage start-up activities conducted by a sub-CRO(s) of relevant country.
Supports the Global Regulatory Submissions group and Project Team in managing local regulatory issues.
Assures accountability for legal and regulatory requirement compliance through working with/employing local regulatory experts.
Helps to ensure that new country regulatory information and changes to local drug law, legal regulations and EC/CA specific requirements are communicated to local and international staff.
Providing detailed day to day operational oversight of the in-country startup team, deliverables and timelines to ensure timelines for site activation are achieved.
Ensuring clear assumptions and country level requirements are provided with timeline commitments.
Pressure testing the in-country teams on delivery, quality, commitments and status to ensure on time delivery.
Review and sign off on initial start-up timelines for awarded work and any re-baselined timelines required.
Proactively escalating risks before issues arise.
Removing country/site level roadblocks
Ensuring sufficient staff levels and competency to complete start-up tasks to plan
Coaching and mentoring staff on how to set local timelines, how to engage sites and to deal with sites directly.
Acting as Country SME for start-up
All other duties as needed or assigned.