Manager, Study Start Up - FSP

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: The Manager, Study Start-up partners closely with the Clinical Operations study team leading global study start-up and site activation activities in Phase I-III and real-world evidence clinical trials. This team member will also partner closely CROs, study teams, vendors, and investigative sites to ensure timely, high-quality, and compliant delivery of start-up milestones. The Manager, Study Start-up provides direct oversight, direction, and support beginning with early study planning, country and site selection, data-driven scenario planning, and enrollment forecasting to ensure predictable and consistent delivery. The Manager, Study Start-up will oversee and ensure the delivery of global (end-to-end) study startup activities (strategy, plans, activities, timelines, and synthesis of study startup insights and presentation to study teams) at program/study level. The Manager, Study Start-Up balances strategic oversight with hands-on responsibilities to ensure predictable delivery of study start-up. This individual will support feasibility, country and site selection, regulatory submissions oversight, site activation deliverables, while driving process improvements and sharing best practices across the organization. The Manager, Study Start-up creates project plans for efficient implementation and oversight of appropriate processes, tools, and technologies to accelerate start-up activities. This candidate leads successful study and site activation oversight by removing complexity, conducting proactive risk mitigation, and removing obstacles for sites to successfully activate within study and corporate objectives.

Requirements

Bachelor’s Degree in Science or related discipline is required
5-7 years of clinical research experience in a CRO or pharma organization, including direct involvement in leading global study start-up and site activation is required
Prior experience overseeing CROs on multinational clinical studies
Working knowledge and strong understanding of study start-up processes: feasibility
Knowledge of ICH/GCP, broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment
Excellent organizational, communication, and problem-solving skills with proven ability to manage competing priorities
Demonstrated ability to build strong relationships with CROs, vendors, and cross-functional partners

Responsibilities

Responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery.
Develop and deliver the global study startup plan by partnering with the CRO Study Startup team.
Drive efficiencies to enhance internal start-up capabilities to align with Trial Delivery Optimization goals.
Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals.
Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning.
Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables and timelines.
Partner with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations.
Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues by utilizing in-country intel and expertise to remove or prevent roadblocks.
Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation.
Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements.
Build and maintain study start-up, country and site activation best practices.
Support inspection/audit readiness by ensuring compliance with GCP, SOPs, and regulatory requirements.
Contribute to continuous improvement initiatives, tool/technology adoption, and knowledge sharing to enhance study start-up efficiency.