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:

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, 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.
• Local Regulatory Expert:
• 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.
• Note - In countries where Global Regulatory Submissions reside, the expertise and regulatory contact with the Competent Authorities may be a GRS representative.
• Study Start-Up and Maintenance:
• 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.

Qualifications (Minimum Required):

• 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.
• Preferred:
• Master’s or other advanced degree.

Experience (Minimum Required):

• Years of experience in the job discipline:
• 3 years supervisory experience.
• Years of experience in other professional roles:
• 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.

What do you get?

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO) – Flex Plan
• Employee recognition awards
• Multiple ERG’s (employee resource groups)
• Target Pay Range based on title: $110-125K

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

#LI - Remote

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